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  • 1.
    Berglund, Åke
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Ullen, Anders
    Karolinska Univ Hosp, Dept Oncol, Solna, Sweden..
    Lisyanskaya, Alla
    City Clin Oncol Ctr, St Petersburg State Healthcare Inst, St Petersburg, Russia..
    Orlov, Sergey
    St Petersburg State Med Univ, State Educ Inst Higher Profess Educ, St Petersburg, Russia..
    Hagberg, Hans
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Lewensohn, Rolf
    Karolinska Univ Hosp, Dept Oncol, Solna, Sweden..
    Nygren, Peter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Spira, Jack
    Oncopeptides AB, Stockholm, Sweden..
    Harmenberg, Johan
    Oncopeptides AB, Stockholm, Sweden..
    Jerling, Markus
    Oncopeptides AB, Stockholm, Sweden..
    Alvfors, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Ringbom, Magnus
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Nordstrom, Eva
    Oncopeptides AB, Stockholm, Sweden..
    Soderlind, Karin
    Oncopeptides AB, Stockholm, Sweden..
    Gullbo, Joachim
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    First-in-human, phase I/IIa clinical study of the peptidase potentiated alkylator melflufen administered every three weeks to patients with advanced solid tumor malignancies2015In: Investigational new drugs, ISSN 0167-6997, E-ISSN 1573-0646, Vol. 33, no 6, p. 1232-1241Article in journal (Refereed)
    Abstract [en]

    Purpose Melflufen (melphalan flufenamide, previously designated J1) is an optimized and targeted derivative of melphalan, hydrolyzed by aminopeptidases overexpressed in tumor cells resulting in selective release and trapping of melphalan, and enhanced activity in preclinical models. Methods This was a prospective, single-armed, open-label, first-in-human, dose-finding phase I/IIa study in 45 adult patients with advanced and progressive solid tumors without standard treatment options. Most common tumor types were ovarian carcinoma (n = 20) and non-small-cell lung cancer (NSCLC, n = 11). Results In the dose-escalating phase I part of the study, seven patients were treated with increasing fixed doses of melflufen (25-130 mg) Q3W. In the subsequent phase IIa part, 38 patients received in total 115 cycles of therapy at doses of 30-75 mg. No dose-limiting toxicities (DLTs) were observed at 25 and 50 mg; at higher doses DLTs were reversible neutropenias and thrombocytopenias, particularly evident in heavily pretreated patients, and the recommended phase II dose (RPTD) was set to 50 mg. Response Evaluation Criteria In Solid Tumors (RECIST) evaluation after 3 cycles of therapy (27 patients) showed partial response in one (ovarian cancer), and stable disease in 18 patients. One NSCLC patient received nine cycles of melflufen and progressed after 7 months of therapy. Conclusions In conclusion, melflufen can safely be given to cancer patients, and the toxicity profile was as expected for alkylating agents; RPTD is 50 mg Q3W. Reversible and manageable bone marrow suppression was identified as a DLT. Clinical activity is suggested in ovarian cancer, but modest activity in treatment of refractory NSCLC.

  • 2.
    Bjurberg, Maria
    et al.
    Lund Univ, Skane Univ Hosp, Dept Haematol Oncol & Radiat Phys, Lasarettsgatan 23, SE-22185 Lund, Sweden;Lund Univ, Dept Clin Sci, Lasarettsgatan 23, SE-22185 Lund, Sweden.
    Holmberg, Erik
    Reg Canc Ctr West, Reg Vastra Gotaland, SE-41345 Gothenburg, Sweden;Sahlgrens Acad, Inst Clin Sci, Dept Oncol, SE-41345 Gothenburg, Sweden.
    Borgfeldt, Christer
    Skane Univ Hosp, Dept Obstet & Gynaecol, SE-22185 Lund, Sweden;Lund Univ, SE-22185 Lund, Sweden.
    Flöter-Rådestad, Angelique
    Karolinska Inst, Karolinska Univ Hosp, Dept Womens & Childrens Hlth, Div Obstet & Gynaecol, SE-17176 Stockholm, Sweden.
    Dahm-Kähler, Pernilla
    Sahlgrens Univ Hosp, Dept Obstet & Gynaecol, SE-41345 Gothenburg, Sweden.
    Hjerpe, Elisabet
    Visby Hosp, Dept Gynaecol & Obstet, SE-62155 Visby, Sweden.
    Högberg, Thomas
    Lund Univ, Dept Canc Epidemiol, SE-22100 Lund, Sweden.
    Kjolhede, Preben
    Linkoping Univ Hosp, Dept Obstet & Gynaecol, SE-58185 Linkoping, Sweden;Linkoping Univ, Dept Clin & Expt Med, SE-58185 Linkoping, Sweden.
    Marcickiewicz, Janusz
    Reg Canc Ctr West, Reg Vastra Gotaland, SE-41345 Gothenburg, Sweden;Halland Hosp, Dept Obstet & Gynaecol, SE-43281 Varberg, Sweden.
    Rosenberg, Per
    Linkoping Univ, Dept Clin & Expt Med, SE-58185 Linkoping, Sweden;Linkoping Univ, Dept Oncol, SE-58185 Linkoping, Sweden.
    Stålberg, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Reproductive Health.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Hellman, Kristina
    Karolinska Univ Hosp, Dept Gynaecol Canc, Theme Canc, SE-17176 Stockholm, Sweden.
    Åvall-Lundqvist, Elisabeth
    Linkoping Univ, Dept Clin & Expt Med, SE-58185 Linkoping, Sweden;Linkoping Univ, Dept Oncol, SE-58185 Linkoping, Sweden.
    Primary treatment patterns and survival of cervical cancer in Sweden: A population-based Swedish Gynecologic Cancer Group Study2019In: Gynecologic Oncology, ISSN 0090-8258, E-ISSN 1095-6859, Vol. 155, no 2, p. 229-236Article in journal (Refereed)
    Abstract [en]

    Objective: Survival in cervical cancer has improved little over the last decades. We aimed to elucidate primary treatment patterns and survival. Methods: Population-based study of patients included in the Swedish Quality Registry for Gynecologic Cancer diagnosed 2011-2015. Main outcome was 5-year relative survival (RS). Age-standardised RS (AS-RS) was estimated for the total cohort and for the pooled study population of squamous, adenosquamous-, adenocarcinoma. Results: Median follow-up time was 4.6 years. The study population consisted of 2141 patients; 97% of the 2212 patients in the total cohort and the 5-year AS-RS was 71% and 70%, respectively. RS stage IB1: surgery alone 95% vs. 72% for definitive chemoradiotherapy (CT-RT) (p < 0.001). In stage IIA1 74% had CTRL, and 47% of operated patients received adjuvant (CT)-RT. RS stage IB2: surgically treated 81% (69% received adjuvant (CT)-RT) vs. 76% for (CT)-RT (p = 0.73). RS stage IIB: 77% for CT-RT + brachytherapy BT), 37% for RT + BT (p = 0.045) and 27% for RT-BT (p < 0.001). Stages III-IVA; <40% received CT-RT + BT, RS 45% vs. 18% for RT-BT (RR 4.1, p < 0.001). RS stage IVB 7%. Conclusion: Primary treatment of cervical cancer in Sweden adhered to evidence-based standard of care. Areas of improvement include optimising treatment for stages III-IVA, and avoiding combining surgery and radiotherapy. (C) 2019 Elsevier Inc. All rights reserved.

  • 3. Gonzalez-Martin, Antonio
    et al.
    Gladieff, Laurence
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Stroyakovsky, Daniel
    Gore, Martin
    Scambia, Giovanni
    Kovalenko, Nadezhda
    Oaknin, Ana
    Ronco, Julian Perez
    Freudensprung, Ulrich
    Pignata, Sandro
    Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer2013In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 49, no 18, p. 3831-3838Article in journal (Refereed)
    Abstract [en]

    Purpose: The single-arm OCTAVIA study evaluated front-line bevacizumab plus weekly paclitaxel and q3w carboplatin. Patients and methods: Patients with newly diagnosed ovarian cancer (International Federation of Gynecology and Obstetrics [FIGO] stage IIb-IV or grade 3/clear-cell stage I/IIA) received bevacizumab (7.5 mg/kg, day 1), weekly paclitaxel (80 mg/m(2) days 1, 8, 15) and carboplatin (area under the curve 6 [AUC6], day 1) intravenously q3w for 6-8 cycles, followed by single-agent bevacizumab (total 1 year). The primary objective was to demonstrate median progression-free survival (PFS) > 18 months according to the lower 90% confidence limit. Secondary end-points included objective response rate, overall survival, safety and tolerability. Results: Most (74%) of the 189 treated patients had stage IIIC/IV disease, similar to the ICON7 population. Patients received a median of six chemotherapy and 17 bevacizumab cycles. At the predefined cutoff 24 months after last patient enrolment, 99 patients (52%) had progressed and 19 (10%) had died, all from ovarian cancer. Median PFS was 23.7 months (95% confidence interval [CI], 19.8-26.4 months), 1-year PFS rate was 85.6%, Response Evaluation Criteria in Solid Tumors (RECIST) response rate was 84.6% and median response duration was 14.7 months. Most patients (>= 90%) completed at least six chemotherapy cycles. Grade >= 3 peripheral sensory neuropathy occurred in 5% and febrile neutropenia in 0.5%. Grade >= 3 adverse events typical of bevacizumab were no more common than in phase III bevacizumab ovarian cancer trials. There was one case of gastrointestinal perforation (0.5%) and no treatment-related deaths. \Conclusion: OCTAVIA met its primary objective, demonstrating median PFS of approximately 2 years. This bevacizumab-containing regimen is active and tolerable.

  • 4. Gonzalez-Martin, Antonio
    et al.
    Gladieff, Laurence
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Stroyakovsky, Daniel
    Gore, Martin
    Scambia, Giovanni
    Oaknin, Ana
    Sneller, Vesna
    Freudensprung, Ulrich
    Pignata, Sandro
    Updated results from OCTAVIA (front-line bevacizumab, carboplatin and weekly paclitaxel therapy for ovarian cancer)2014In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 50, no 4, p. 862-863Article in journal (Refereed)
  • 5.
    Hjerpe, Elisabet
    et al.
    Karolinska Univ Hosp, Dept Pathol & Oncol, Stockholm.; Karolinska Inst, Dept Oncol & Pathol, Stockholm.
    Staf, Christian
    Sahlgrens Univ Hosp, Reg Canc Ctr Western Sweden, Gothenburg.
    Dahm-Kähler, Pernilla
    Sahlgrens Univ Hosp, Dept Obstet & Gynecol, Gothenburg.
    Stålberg, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Reproductive Health.
    Bjurberg, Maria
    Skåne Univ Hosp, Dept Hematol Oncol & Radiat Phys, Lund.; Lund Univ, Dept Clin Sci, Lund.
    Holmberg, Erik
    Sahlgrens Univ Hosp, Reg Canc Ctr Western Sweden, Gothenburg.; Sahlgrens Acad, Inst Clin Sci, Gothenburg.
    Borgfeldt, Christer
    Skåne Univ Hosp, Dept Obstet & Gynecol, Lund.; Lund Univ, Lund.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Hellman, Kristina
    Karolinska Univ Hosp, Dept Pathol & Oncol, Stockholm.; Karolinska Inst, Dept Oncol & Pathol, Stockholm.
    Kjølhede, Preben
    Linköping Univ Hosp, Dept Obstet & Gynecol, Linköping.; Linköping Univ, Dept Clin & Expt Med, Linköping.
    Högberg, Thomas
    Lund Univ, Dept Canc Epidemiol, Lund.
    Rosenberg, Per
    Linköping Univ, Dept Clin & Expt Med, Linköping.; Linköping Univ, Dept Clin Oncol, Linköping.
    Åvall-Lundqvist, Elisabeth
    Karolinska Inst, Dept Oncol & Pathol, Stockholm; Linköping Univ, Dept Clin & Expt Med, Linköping.; Linköping Univ, Dept Clin Oncol, Linköping.
    Lymph node metastases as only qualifier for stage IV serous ovarian cancer confers longer survival than other sites of distant disease - a Swedish Gynecologic Cancer Group (SweGCG) study2018In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 57, no 3, p. 331-337Article in journal (Refereed)
    Abstract [en]

    Background: The International Federation of Gynecology and Obstetrics (FIGO) ovarian cancer staging system includes no sub-stage for lymph nodes (LN) as only distant disease manifestation. We explore the prognostic implication of LN as only stage IV classifier in serous ovarian cancer.

    Method: This is a nation-wide, population-based study on 551 women with serous stage IV cancers diagnosed between 2009–2014. We compare overall survival (OS) in women with LN as only distant metastatic site to those with pleural metastases only and to patients with other/multiple stage IV manifestations. Cox regression models were used for uni- and multivariable estimations.

    Results: Of 551stage IV cases, distant metastatic site was registered in 433. Median OS for women with LN (n = 51) was 41.4 months, compared to 25.2 and 26.8 months for patients with pleural (n = 195) or other/multiple (n = 187) distant metastases (p = .0007). The corresponding five-year survival rates were 32, 11 and 22%, respectively. Multivariable analyzes confirmed shorter survival for women with pleural (HR 2.99, p = .001) or other/multiple distant sites (HR 2.67, p = .007), as compared to LN cases. LN only patients lived 9.1 months longer after primary than after interval surgery, but this difference was not significant (p = .245).

    Conclusion: Women with stage IV serous ovarian cancer having lymph nodes as only distant metastatic site live longer than other stage IV patients.

  • 6. Hogberg, T.
    et al.
    Bangshoj, R.
    Bjurberg, M.
    Boman, K.
    Bulow, E.
    Dahm-Kahler, P.
    Holtenman, M.
    Rosenberg, P.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Avall-Lundqvist, E.
    The Swedish Quality Registry for Gynecologic Oncology2013In: International Journal of Gynecological Cancer, ISSN 1048-891X, E-ISSN 1525-1438, Vol. 23, no 8Article in journal (Other academic)
  • 7.
    Pujade-Lauraine, Eric
    et al.
    Ctr Cancs Femme & Rech Clin, Paris, France..
    Selle, Frederic
    Hop Univ Est Parisien Site Tenon, Paris, France.;Alliance Rech Cancerol, Paris, France..
    Weber, Beatrice
    Ctr Alexis Vautrin, Vandoeuvre Les Nancy, France..
    Ray-Coquard, Isabelle-Laure
    Ctr Leon Berard, F-69373 Lyon, France.;Univ Lyon 1, F-69365 Lyon, France..
    Vergote, Ignace
    Univ Lyon 1, F-69365 Lyon, France.;Katholieke Univ Leuven, Univ Hosp Leuven, Leuven, Belgium..
    Sufliarsky, Jozef
    Natl Canc Inst, Bratislava, Slovakia..
    Del Campo, Josep Maria
    Univ Hosp, Vall Dhebron, Spain..
    Lortholary, Alain
    Ctr Catherine Sienne, Nantes, France..
    Lesoin, Anne
    Ctr Oscar Lambret, F-59020 Lille, France..
    Follana, Philippe
    Ctr Antoine Lacassagne, 36 Voie Romaine, F-06054 Nice, France..
    Freyer, Gilles
    Lyon Univ, Hosp Civils Lyon, Pierre Benite, France..
    Pardo, Beatriz
    Inst Catala Oncol, Inst Invest Biomed Bellvitge, Barcelona, Spain..
    Vidal, Laura
    Hosp Clin Barcelona, Barcelona, Spain..
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Gladieff, Laurence
    Inst Claudius Regaud IUCTO, Toulouse, France..
    Sassi, Mouna
    Boehringer Ingelheim GmbH & Co KG, Reims, France..
    Garin-Chesa, Pilar
    Boehringer Ingelheim GmbH & Co KG, Vienna, Austria..
    Nazabadioko, Serge
    Boehringer Ingelheim GmbH & Co KG, Reims, France..
    Marzin, Kristell
    Boehringer Ingelheim GmbH & Co KG, Biberach, Germany..
    Pilz, Korinna
    Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany..
    Joly, Florence
    Ctr Francois Baclesse, F-14021 Caen, France..
    Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study2016In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 34, no 7, p. 706-+Article in journal (Refereed)
    Abstract [en]

    Purpose Volasertib is a potent and selective cell-cycle kinase inhibitor that induces mitotic arrest and apoptosis by targeting Polo-like kinase. This phase II trial evaluated volasertib or single-agent chemotherapy in patients with platinum-resistant or -refractory ovarian cancer who experienced failure after treatment with two or three therapy lines. Patients and Methods Patients were randomly assigned to receive either volasertib 300 mg by intravenous infusion every 3 weeks or an investigator's choice of single-agent, nonplatinum, cytotoxic chemotherapy. The primary end point was 24-week disease control rate. Secondary end points included best overall response, progression-free survival (PFS), safety, quality of life, and exploratory biomarker analyses. Results Of the 109 patients receiving treatment, 54 received volasertib and 55 received chemotherapy; demographics were well balanced. The 24-week disease control rates for volasertib and chemotherapy were 30.6% (95% CI, 18.0% to 43.2%) and 43.1% (95% CI, 29.6% to 56.7%), respectively, with partial responses in seven (13.0%) and eight (14.5%) patients, respectively. Median PFS was 13.1 weeks and 20.6 weeks for volasertib and chemotherapy (hazard ratio, 1.01; 95% CI, 0.66 to 1.53). Six patients (11%) receiving volasertib achieved PFS fore more than 1 year, whereas no patient receiving chemotherapy achieved PFS greater than 1 year. No relationship between the expression of the biomarkers tested and their response was determined. Patients treated with volasertib experienced more grade 3 and 4 drug-related hematologic adverse events (AEs) and fewer nonhematologic AEs than did patients receiving chemotherapy. Discontinuation resulting from AEs occurred in seven (13.0%) and 15 (27.3%) patients in the volasertib and chemotherapy arms, respectively. Both arms showed similar effects on quality of life. Conclusion Single-agent volasertib showed antitumor activity in patients with ovarian cancer. AEs in patients receiving volasertib were mainly hematologic and manageable.

  • 8.
    Rosenberg, Per
    et al.
    Linköping Univ, Dept Oncol, Linköping; Linköping Univ, Dept Clin & Expt Med, Linköping.
    Kjølhede, Preben
    Linköping Univ, Dept Clin & Expt Med, Linköping.;Linköping Univ, Dept Obstet & Gynecol, Linköping.
    Staf, Christian
    Reg Canc Ctr, Gothenburg; Sahlgrens Univ Hosp, Gothenburg.
    Bjurberg, Maria
    Skåne Univ Hosp, Dept Clin Sci, Lund.
    Borgfeldt, Christer
    Lund Univ, Dept Obstet & Gynecol, Skåne Univ Hosp, Lund.
    Dahm-Kähler, Pernilla
    Sahlgrens Univ Hosp, Dept Obstet & Gynecol, Gothenburg; Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Gothenburg.
    Hellman, Kristina
    Karolinska Inst, Dept Pathol & Oncol, Stockholm.
    Hjerpe, Elisabet
    Karolinska Inst, Dept Pathol & Oncol, Stockholm.
    Holmberg, Erik
    Reg Canc Ctr, Gothenburg.; Sahlgrens Univ Hosp, Gothenburg.; Univ Gothenburg, Inst Clin Sci, Dept Oncol, Sahlgrenska Acad, Gothenburg.
    Stålberg, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Reproductive Health.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Lundqvist, Elisabeth Avall
    Linköping Univ, Dept Oncol, Linköping.;Linköping Univ, Dept Clin & Expt Med, Linköping.
    Hogberg, Thomas
    Lund Univ, Dept Canc Epidemiol, Lund.
    Data quality in the Swedish Quality Register of Gynecologic Cancer - a Swedish Gynecologic Cancer Group (SweGCG) study2018In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 57, no 3, p. 346-353Article in journal (Refereed)
    Abstract [en]

    Aim: The aim of this study is to evaluate the quality of data on endometrial (EC) and ovarian, fallopian tube, peritoneal, abdominal or pelvic cancers (OC) registered in the Swedish Quality Register of Gynecologic Cancer (SQRGC).

    Method: A random sample of 500 patients was identified in the SQRGC and their medical charts were reviewed for re-abstraction of 31 selected core variables by an independent validator. The data in the SQRGC and the re-abstracted data were compared. The data were collected from 25 hospitals evenly distributed throughout Sweden. The main outcomes were comparability, timeliness, completeness and validity. Coverage was compared with the National Cancer Register (NCR). Timeliness was defined as the speed of registration i.e. when patients were registered in the SQRGC relative to date of diagnosis. Internationally accepted coding systems for stage, grading and histologic type were used ensuring a high degree of comparability. Correlations were estimated using Pearson’s correlation coefficient and Cohen´s kappa coefficient.

    Results: The completeness was 95%. The timeliness was 88–91% within 12 months of diagnosis. The median degree of agreement between re-abstracted data and data in the SQRGC was 82.1%, with a median kappa value of 0.73 for ordinate variables and a median Pearson’s correlation coefficient of 0.96. The agreements for the type of surgery were 76% (95% CI 70–81%; kappa 0.49) and type of primary treatment 90% (95% CI 87–94%; kappa 0.85) in OC and in EC 88% (95% CI 84–93%; kappa 0.84). The agreements for the FIGO stage were in OC and EC 74% (95% CI 68–80%; kappa 0.69) and 87% (95% CI 82–91%; kappa 0.79), respectively.

    Conclusions: The data in the Swedish Quality Register for Gynecologic Cancer are of adequate quality in order to be used as a basis for research and to evaluate possible differences in treatment, lead times and treatment results.

  • 9.
    Soletormos, Gyorgy
    et al.
    Univ Copenhagen, North Zealand Hosp, Dept Clin Biochem, DK-3400 Hillerod, Denmark..
    Duffy, Michael J.
    St Vincents Univ Hosp, Clin Res Ctr, Dublin 4, Ireland.;Univ Coll Dublin, UCD Sch Med & Med Sci, Conway Inst Bimol & Biomed, Res, Dublin 2, Ireland..
    Abu Hassan, Suher Othman
    Univ Copenhagen, North Zealand Hosp, Dept Clin Biochem, DK-3400 Hillerod, Denmark..
    Verheijen, Rene H. M.
    Univ Med, Ctr Utrecht, Dept Gynecol Oncol, Utrecht, Netherlands..
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Bast, Robert C., Jr.
    Univ Texas MD Anderson Canc Ctr, Div Canc Med, Dept Gynecol Med Oncol, Houston, TX 77030 USA..
    Gaarenstroom, Katja N.
    Leiden Univ, Med Ctr, Dept Gynecol, Leiden, Netherlands..
    Sturgeon, Catharine M.
    Royal Infirm Edinburgh NHS Trust, Dept Clin Biochem, Edinburgh, Midlothian, Scotland..
    Bonfrer, Johannes M.
    PUM Netherlands Senior Experts, Senior Expert Clin Labs, Heemstede, Netherlands..
    Petersen, Per Hyltoft
    Univ Bergen, Norwegian Qual Improvement Primary Care Labs NOKL, Sect Gen Practice, Bergen, Norway..
    Troonen, Hugo
    Abbott, Limburg, Germany..
    CarloTorre, Gian
    Ctr Ippocrate, Bogliasco, Italy..
    Kulpa, Jan Kanty
    M Sklodowska Curie Mem Inst, Cracow Div, Ctr Oncol, Dept Clin Biochem, Krakow, Poland..
    Tuxen, Malgorzata K.
    Univ Copenhagen, Herlev Hosp, Dept Oncol, DK-2730 Herlev, Denmark..
    Molina, Raphael
    Hosp Clin Barcelona, Biochem Lab, Barcelona, Spain..
    Clinical Use of Cancer Biomarkers in Epithelial Ovarian Cancer Updated Guidelines From the European Group on Tumor Markers2016In: International Journal of Gynecological Cancer, ISSN 1048-891X, E-ISSN 1525-1438, Vol. 26, no 1, p. 43-51Article in journal (Refereed)
    Abstract [en]

    Objective:To present an update of the European Group on Tumor Markers guidelines for serum markers in epithelial varian cancer. Methods: Systematic literature survey from 2008 to 2013. The articles were evaluated by level of evidence and strength of recommendation. Results: Because of its low sensitivity (50-62% for early stage epithelial ovarian cancer) and limited specificity (94-98.5%), cancer antigen (CA) 125 (CA125) is not recommended as a screening test in asymptomatic women. The Risk of Malignancy Index, which includes CA125, transvaginal ultrasound, and menopausal status, is recommended for the differential diagnosis of a pelvic mass. Because human epididymis protein 4 has been reported to have superior specificity to CA125, especially in premenopausal women, it may be considered either alone or as part of the risk of ovarian malignancy algorithm, in the differential diagnosis of pelvic masses, especially in such women. CA125 should be used to monitor response to first-line chemotherapy using the previously published criteria of the Gynecological Cancer Intergroup, that is, at least a 50% reduction of a pretreatment sample of 70 kU/L or greater. The value of CA125 in posttherapy surveillance is less clear. Although a prospective randomized trial concluded that early administration of chemotherapy based on increasing CA125 levels had no effect on survival, European Group on Tumor Markers state that monitoring with CA125 in this situation should occur, especially if the patient is a candidate for secondary cytoreductive surgery. Conclusions: At present, CA125 remains the most important biomarker for epithelial ovarian cancer, excluding tumors of mucinous origin.

  • 10. Soletormos, Gyorgy
    et al.
    Duffy, Michael J.
    Hayes, Daniel F.
    Sturgeon, Catharine M.
    Barak, Vivian
    Bossuyt, Patrick M.
    Diamandis, Eleftherios P.
    Gion, Massimo
    Hyltoft-Petersen, Per
    Lamerz, Rolf M.
    Nielsen, Dorte L.
    Sibley, Paul
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Tuxen, Malgorzata K.
    Bonfrer, Johannes M. G.
    Design of Tumor Biomarker-Monitoring Trials: A Proposal by the European Group on Tumor Markers2013In: Clinical Chemistry, ISSN 0009-9147, E-ISSN 1530-8561, Vol. 59, no 1, p. 52-59Article in journal (Refereed)
    Abstract [en]

    A major application of tumor biomarkers is in serial monitoring of cancer patients, but there are no published guidelines on how to evaluate biomarkers for this purpose. The European Group on Tumor Markers has convened a multidisciplinary panel of scientists to develop guidance on the design of such monitoring trials. The panel proposes a 4-phase model for biomarker-monitoring trials analogous to that in use for the investigation of new drugs. In phase I, biomarker kinetics and correlation with tumor burden are assessed. Phase II evaluates the ability of the biomarker to identify, exclude, and/or predict a change in disease status. In phase III, the effectiveness of tumor biomarker guided intervention is assessed by measuring patient outcome in randomized trials. Phase IV consists of an audit of the long-term effects after biomarker monitoring has been included into standard patient care. Systematic well-designed evaluations of biomarkers for monitoring may provide a stronger evidence base that might enable their earlier use in evaluating responses to cancer therapy.

  • 11.
    Stålberg, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Reproductive Health.
    Bjurberg, Maria
    Skane Univ Hosp Lund, Dept Hematol Oncol & Radiat Phys, Lund, Sweden;Lund Univ, Dept Clin Sci, Lund, Sweden.
    Borgfeldt, Christer
    Lund Univ, Dept Clin Sci, Lund, Sweden;Skane Univ Hosp, Dept Obstet & Gynecol, Lund, Sweden.
    Carlson, Joseph
    Karolinska Univ Hosp, Dept Pathol & Cytol, Stockholm, Sweden;Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.
    Dahm-Kähler, Pernilla
    Gothenburg Univ, Sahgrenska Univ Hosp, Sahlgrenska Acad, Dept Obstet & Gynecol, Gothenburg, Sweden.
    Flöter-Rådestad, Angelique
    Karolinska Inst, Dept Obstet & Gynecol, Stockholm, Sweden.
    Hellman, Kristina
    Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden;Karolinska Univ Hosp, Dept Oncol & Pathol, Stockholm, Sweden.
    Hjerpe, Elisabet
    Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden;Karolinska Univ Hosp, Dept Oncol & Pathol, Stockholm, Sweden.
    Holmberg, Erik
    Sahlgrens Acad, Inst Clin Sci, Dept Oncol, Gothenburg, Sweden;Sahlgrens Univ Hosp, Reg Canc Ctr Vast, Gothenburg, Sweden.
    Kjølhede, Preben
    Linkoping Univ, Dept Obstet & Gynecol, Linkoping, Sweden;Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden.
    Marcickiewicz, Janusz
    Reg Canc Ctr Vast, Gothenburg, Sweden;Hallands Hosp Varberg, Dept Obstet & Gynecol, Varberg, Sweden.
    Rosenberg, Per
    Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden;Linkoping Univ, Dept Clin Oncol, Linkoping, Sweden.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Åvall-Lundqvist, Elisabeth
    Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden;Linkoping Univ, Dept Clin Oncol, Linkoping, Sweden.
    Högberg, Thomas
    Lund Univ, Dept Canc Epidemiol, Lund, Sweden.
    Lymphovascular space invasion as a predictive factor for lymph node metastases and survival in endometrioid endometrial cancer: a Swedish Gynecologic Cancer Group (SweGCG) study2019In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 58, no 11, p. 1628-1633Article in journal (Refereed)
    Abstract [en]

    Background: The aim of this study is to evaluate the impact of lymphovascular space invasion (LVSI) on the risk of lymph node metastases and survival in endometrioid endometrial adenocarcinoma.

    Material and methods: As regard the study design, this is a cohort study based on prospectively recorded data. Patients with endometrioid endometrial adenocarcinoma registered in the Swedish Quality Registry for Gynecologic Cancer 2010–2017 with FIGO stages I–III and verified nodal status were identified (n = 1587). LVSI together with established risk factors, namely DNA ploidy, FIGO grade, myometrial invasion and age, were included in multivariable regression analyses with lymph node metastases as the dependent variable. Associations between the risk factors and overall and relative survival were included in multivariable models. Estimates of risk ratios (RR), hazard ratios (HR), excess mortality rate ratios (EMR), and 95% confidence intervals (95% CI) were calculated.

    Results: The presence of LVSI presented the strongest association with lymph node metastases (RR = 5.46, CI 3.69–8.07, p < .001) followed by deep myometrial invasion (RR = 1.64, CI 1.13–2.37). In the multivariable survival analyses, LVSI (EMR = 7.69, CI 2.03–29.10,) and non-diploidy (EMR = 3.23, CI 1.25–8.41) were associated with decreased relative survival. In sub-analyses including only patients with complete para-aortic and pelvic lymphadenectomy and negative lymph nodes (n = 404), only LVSI (HR = 2.50, CI 1.05–5.98) was associated with a worsened overall survival.

    Conclusion: This large nationwide study identified LVSI as the strongest independent risk factor for lymph node metastases and decreased survival in patients with endometrioid adenocarcinomas. Moreover, decreased overall survival was also seen in patients with LVSI-positive tumors and negative lymph nodes, indicating that hematogenous dissemination might also be important.

  • 12.
    Stålberg, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Obstetrics and Gynaecology.
    Falconer, H.
    Karolinska Inst, Dept Womens & Childrens Hlth, Div Obstet & Gynecol, Stockholm, Sweden..
    Bjurberg, M.
    Lund Univ, Dept Hematol Oncol & Radiat Phys, Skane Univ Hosp, Lund, Sweden.;Dept Clin Sci, Div Oncol & Pathol, Lund, Sweden..
    Borgfeldt, C.
    Lund Univ, Dept Obstet & Gynecol, Skane Univ Hosp, Lund, Sweden..
    Dahm-Kahler, P.
    Univ Gothenburg, Sahlgrenska Acad, Sahlgrenska Univ Hosp, Inst Clin Sci,Dept Obstet & Gynecol, Gothenburg, Sweden..
    Holmberg, E.
    Univ Gothenburg, Sahlgrenska Acad, Sahlgrenska Univ Hosp, Inst Clin Sci,Dept Obstet & Gynecol, Gothenburg, Sweden..
    Kjolhede, P.
    Linkoping Univ, Dept Clin & Expt Med, Dept Obstet & Gynecol, Linkoping, Sweden..
    Staf, C.
    Univ Gothenburg, Sahlgrenska Acad, Sahlgrenska Univ Hosp, Inst Clin Sci,Dept Obstet & Gynecol, Gothenburg, Sweden..
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Avall-Lundqvist, E.
    Linkoping Univ, Dept Clin & Expt Med, Dept Obstet & Gynecol, Linkoping, Sweden..
    Rosenberg, P.
    Linkoping Univ, Dept Oncol, Linkoping, Sweden..
    Högberg, T.
    Lund Univ, Dept Canc Epidemiol, Skane Univ Hosp, Lund, Sweden..
    Risk Factors For Lymph Node Metastases In Women With Endometrial Cancer: A Population-Based, Nation-Wide Registry Study2016In: International Journal of Gynecological Cancer, ISSN 1048-891X, E-ISSN 1525-1438, Vol. 26, p. 208-209Article in journal (Other academic)
  • 13.
    Stålberg, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
    Kjolhede, P.
    Linkopings Univ, Dept Obstet & Gynecol, Linkoping, Sweden.;Linkopings Univ, Dept Clin & Expt Med, Linkoping, Sweden..
    Bjurberg, M.
    Skanes Univ Sjukhus, Dept Hematol Oncol & Radiat Phys, Lund, Sweden.;Lund Univ, Div Oncol & Pathol, Dept Clin Sci, Lund, Sweden..
    Borgfeldt, C.
    Lund Univ, Skane Univ Hosp, Dept Obstet & Gynecol, Lund, Sweden..
    Dahm-Kahler, P.
    Univ Gothenburg, Sahlgrenska Acad, Dept Obstet & Gynecol, Gothenburg, Sweden..
    Falconer, H.
    Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden..
    Holmberg, E.
    Sahlgrens Univ Hosp, Reg Canc Ctr Western Sweden, Gothenburg, Sweden.;Gothenburg Univ, Sahlgrenska Akad, Inst Clin Sci, Gothenburg, Sweden..
    Staf, C.
    Sahlgrens Univ Hosp, Reg Canc Ctr Western Sweden, Gothenburg, Sweden..
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
    Avall-Lundqvist, E.
    Linkopings Univ, Dept Oncol, Linkoping, Sweden.;Linkopings Univ, Dept Clin & Expt Med, Linkoping, Sweden.;Karolinska Inst, Dept Pathol & Oncol, Stockholm, Sweden..
    Rosenberg, P.
    Univ Sjukhuset Linkoping, Dept Oncol Hogberg, Linkoping, Sweden..
    Hogberg, T.
    Lund Univ, Skane Univ Hosp, Dept Canc Epidemiol, Lund, Sweden..
    Risk factors for lymph node metastases in women with endometrial cancer: A population-based, nation-wide register study—On behalf of the Swedish Gynecological Cancer Group2017In: International Journal of Cancer, ISSN 0020-7136, E-ISSN 1097-0215, Vol. 140, no 12, p. 2693-2700Article in journal (Refereed)
    Abstract [en]

    The role of lymphadenectomy in the management of early endometrial cancer remains controversial. In the recent ESMO-ESGO-ESTRO guidelines, lymphadenectomy is recommended for patients with endometrioid adenocarcinoma Grade 3 with deep myometrial invasion, but complete agreement was not achieved. In Sweden, DNA aneuploidy has been included as a high-risk factor. The aim of our study was to evaluate the impact of tumor histology, FIGO grade, DNA ploidy and myometrial invasion (MI) on occurrence of lymph node metastasis (LNM) in patients with endometrial cancer. The study design is a retrospective cohort study based on prospectively recorded register data. Endometrial cancer patients registered in the Swedish Quality Registry for Gynecologic Cancer 2010-2015 with FIGO Stages I-III and verified nodal status were included. Data on DNA ploidy, histology, FIGO grade and MI were included in multivariable log-binomial regression analyses with LNM as dependent variable. 1,165 cases fulfilled the inclusion criteria. The multivariable analyses revealed increased risk of LNM in patients with tumors with MI50% (risk ratio [RR]=4.1; 95% confidence interval [CI] 3.0-5.6), nonendometrioid compared to endometrioid histology (RR 1.8; CI 1.4-2.4) and FIGO Grade 3 compared to Grade 1-2 tumors (RR 1.5; CI 1.1-2.0). No statistically significant association between DNA ploidy status and LNM was detected. This population-based, nation-wide study in women with endometrial cancer confirms a strong association between MI50%, nonendometrioid histology and FIGO Grade 3, respectively, and LNM. DNA ploidy should not be included in the preoperative decision making of removing nodes or not. What's new? Whether lymphadenectomy is beneficial for women with endometrial cancer remains uncertain. Moreover, additional studies are needed to explore factors that reliably predict lymph node metastasis (LNM). Here, multiple factors, including tumor histology, grade of differentiation and DNA aneuploidy, were evaluated for associations with LNM risk in women with endometrial cancer and verified lymph node status. Most significantly, deep myometrial invasion in tumors increased LNM risk fourfold, whereas DNA ploidy had essentially no impact on LNM risk. The findings confirm the predictive relevance of myometrial invasion, histology and grade reported in previous single-center and multicenter studies.

  • 14.
    Stålberg, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
    Svensson, T.
    Department of Medicine, Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.
    Granath, F.
    Department of Medicine, Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.
    Kieler, H.
    Department of Medicine, Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Lonn, S.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Evaluation of prevalent and incident ovarian cancer co-morbidity2012In: British Journal of Cancer, ISSN 0007-0920, E-ISSN 1532-1827, Vol. 106, no 11, p. 1860-1865Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: The peak in incidence of ovarian cancer occurs around 65 years and concurrent increasing risk by age for a number of diseases strongly influence treatment and prognosis. The aim was to explore prevalence and incidence of co-morbidity in ovarian cancer patients compared with the general population.

    METHODS: The study population was patients with ovarian cancer in Sweden 1993-2006 (n = 11 139) and five controls per case (n = 55 687). Co-morbidity from 1987 to 2006 was obtained from the Swedish Patient Register. Prevalent data were analysed with logistic regression and incident data with Cox proportional hazards models.

    RESULTS: Women developing ovarian cancer did not have higher overall morbidity than other women earlier than 3 months preceding cancer diagnosis. However, at time of diagnosis 11 of 13 prevalent diagnosis groups were more common among ovarian cancer patients compared with controls. The incidence of many common diagnoses was increased several years following the ovarian cancer and the most common diagnoses during the follow-up period were thromboembolism, haematologic and gastrointestinal complications.

    CONCLUSION: Women developing ovarian cancer do not have higher overall morbidity the years preceding cancer diagnosis. The incidence of many common diagnoses was increased several years following the ovarian cancer. It is crucial to consider time between co-morbidity and cancer diagnosis to understand and interpret associations.

  • 15.
    Stålberg, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Obstetrics and Gynaecology.
    Svensson, Tobias
    Granath, Fredrik
    Kieler, Helle
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Lonn, Stefan
    Evaluation of prevalent and incident ovarian cancer co-morbidity2012In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 91, p. 129-129Article in journal (Other academic)
  • 16.
    von Heideman, Anne
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Tholander, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    Grundmark, Birgitta
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
    Cajander, Stefan
    Gerdin, Eva
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
    Holm, Leif
    Axelsson, Agneta
    Rosenberg, Per
    Mahteme, Haile
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Colorectal Surgery.
    Daniel, Erika
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science.
    Larsson, Rolf
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cancer Pharmacology and Computational Medicine.
    Nygren, Peter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science.
    Chemotherapeutic drug sensitivity of primary cultures of epithelial ovarian cancer cells from patients in relation to tumour characteristics and therapeutic outcome2014In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 53, no 2, p. 242-250Article in journal (Refereed)
    Abstract [en]

    Background

    A number of chemotherapeutic drugs are active in epithelial ovarian cancer (EOC) but so far choice of drugs for treatment is mostly empirically based. Testing of drug activity in tumour cells from patients might provide a rationale for a more individualised approach for drug selection.

    Material and methods

    Sensitivity of EOC to chemotherapeutic drugs was analysed in 125 tumour samples from 112 patients using a short-term primary culture assay based on the concept of total cell kill. Sensitivity was related to tumour histology, treatment status and clinical tumour response.

    Results

    For most EOC standard drugs serous high grade and clear cell EOC were the most sensitive subtypes and the mucinous tumours the most resistant subtype. Docetaxel, however, tended to show the opposite pattern. Samples from previously treated patients tended to be more resistant than those from treatment naive patients. The activity of cisplatin correlated with that of other drugs with the exception of docetaxel. Tumour samples from two sites in the same patient at the same occasion showed similar cisplatin sensitivity in contrast to samples taken at different occasions. Samples from patients responding in the clinic to treatment were more sensitive to most drugs than samples from non-responding patients. At the individual patient level, drug sensitivity in vitro compared with clinical response showed sensitivities and specificities in the 83-100% and 55-83% ranges, respectively.

    Conclusions

    Assessment of EOC tumour cell drug sensitivity in vitro provides clinically relevant and potentially useful information for the optimisation of drug treatment.

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