13 results on '"Verhoeven-Adema, Karen W."'
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2. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial
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McCormack, M, Whitmarsh, K, Allerton, R, Gregory, D, Symonds, P, Hoskin, PJ, Adusumalli, M, Anand, A, Wade, R, Stewart, A, Taylor, W, Lutgens, LCHW, Hollema, H, Pras, E, Snyers, A, Westerveld, GH, Jobsen, JJ, Slot, A, Mens, JM, Stam, TC, Van Triest, B, Van der Steen-Banasik, EM, De Winter, KAJ, Quinn, MA, Kolodziej, I, Pyman, J, Johnson, C, Capp, A, Fossati, R, Colombo, A, Carinelli, S, Ferrero, A, Artioli, G, Davidson, C, McLachlin, CM, Ghatage, P, Rittenberg, PVC, Souhami, L, Thomas, G, Duvillard, P, Berton-Rigaud, D, Tubiana-Mathieu, N, de Boer, Stephanie M, Powell, Melanie E, Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B, Ledermann, Jonathan A, Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie-Helene, Jürgenliemk-Schulz, Ina M, Kitchener, Henry C, Nijman, Hans W, Wilson, Godfrey, Brooks, Susan, Gribaudo, Sergio, Provencher, Diane, Hanzen, Chantal, Kruitwagen, Roy F, Smit, Vincent T H B M, Singh, Naveena, Do, Viet, Lissoni, Andrea, Nout, Remi A, Feeney, Amanda, Verhoeven-Adema, Karen W, Putter, Hein, and Creutzberg, Carien L
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- 2019
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3. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial
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de Boer, Stephanie M, Powell, Melanie E, Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B, Ledermann, Jonathan A, Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie-Helene, Kitchener, Henry C, Nijman, Hans W, Kruitwagen, Roy F, Nout, Remi A, Verhoeven-Adema, Karen W, Smit, Vincent T, Putter, Hein, and Creutzberg, Carien L
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- 2016
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4. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial
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de Boer, Stephanie M., Nout, Remi A., Jürgenliemk-Schulz, Ina M., Jobsen, Jan J., Lutgens, Ludy C.H.W., van der Steen-Banasik, Elzbieta M., Mens, Jan Willem M., Slot, Annerie, Stenfert Kroese, Marika C., Oerlemans, Simone, Putter, Hein, Verhoeven-Adema, Karen W., Nijman, Hans W., and Creutzberg, Carien L.
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- 2015
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5. Molecular Classification Predicts Response to Radiotherapy in the Randomized PORTEC-1 and PORTEC-2 Trials for Early-Stage Endometrioid Endometrial Cancer.
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Horeweg, Nanda, Nout, Remi A., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy C.H.W., Jobsen, Jan J., Haverkort, Marie A.D., Mens, Jan Willem M., Slot, Annerie, Wortman, Bastiaan G., de Boer, Stephanie M., Stelloo, Ellen, Verhoeven-Adema, Karen W., Putter, Hein, Smit, Vincent T.H.B.M., Bosse, Tjalling, Creutzberg, Carien L., Creutzberg, C.L., Koper, P.C.M., van Putten, W.L.J., and Dercksen, R.
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- 2023
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6. Long-term toxicity and health-related quality of life after adjuvant chemoradiotherapy or radiotherapy alone for high-risk endometrial cancer in the randomised PORTEC-3 trial
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Post, C, de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, N, Ledermann, J, Khaw, P, D'Amico, R, Fyles, A, Baron, M, Kitchener, H, Nijman, H, Lutgens, L, Brooks, S, Jürgenliemk-Schulz, I, Feeney, A, Goss, G, Fossati, R, Ghatage, P, Leary, A, Do, V, Lissoni, A, Mccormack, M, Nout, R, Verhoeven-Adema, K, Smit, V, Putter, H, Creutzberg, C, Post, Cathalijne C B, de Boer, Stephanie M, Powell, Melanie E, Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke P B, Ledermann, Jonathan A, Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C, Nijman, Hans W, Lutgens, Ludy C H W, Brooks, Susan, Jürgenliemk-Schulz, Ina M, Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A, McCormack, Mary, Nout, Remi A, Verhoeven-Adema, Karen W, Smit, Vincent T H B M, Putter, Hein, Creutzberg, Carien L, Post, C, de Boer, S, Powell, M, Mileshkin, L, Katsaros, D, Bessette, P, Haie-Meder, C, Ottevanger, N, Ledermann, J, Khaw, P, D'Amico, R, Fyles, A, Baron, M, Kitchener, H, Nijman, H, Lutgens, L, Brooks, S, Jürgenliemk-Schulz, I, Feeney, A, Goss, G, Fossati, R, Ghatage, P, Leary, A, Do, V, Lissoni, A, Mccormack, M, Nout, R, Verhoeven-Adema, K, Smit, V, Putter, H, Creutzberg, C, Post, Cathalijne C B, de Boer, Stephanie M, Powell, Melanie E, Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke P B, Ledermann, Jonathan A, Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C, Nijman, Hans W, Lutgens, Ludy C H W, Brooks, Susan, Jürgenliemk-Schulz, Ina M, Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A, McCormack, Mary, Nout, Remi A, Verhoeven-Adema, Karen W, Smit, Vincent T H B M, Putter, Hein, and Creutzberg, Carien L
- Abstract
Background: The survival results of the PORTEC-3 trial showed a significant improvement in both overall and failure-free survival with chemoradiotherapy versus pelvic radiotherapy alone. The present analysis was performed to compare long-term adverse events (AE) and health-related quality of life (HRQOL). Patients and methods: 660 women with high-risk endometrial cancer were randomly assigned to receive chemoradiotherapy (2 concurrent cycles of cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiotherapy alone. Toxicity was graded using CTCAE v3.0. HRQOL was measured using EORTC QLQ-C30 and CX24/OV28-subscales and compared to normative-data. An as-treated analysis was performed. Results: Median follow up was 74.6 months; 574 (87%) patients were evaluable for HRQOL. At 5 years, grade ≥2 AE were scored for 78 (38%) patients who had received chemoradiotherapy versus 46 (24%) who had received radiotherapy (p=0.008). Grade 3 AE did not differ significantly between the groups (8% vs 5%, p=0.18) at 5 years, and only one new late grade 4 toxicity had been reported. At 3 and 5 years, sensory neuropathy toxicity grade ≥2 persisted after chemoradiotherapy in 6% (vs 0% after radiotherapy, p<0.001) and more patients reported significant tingling or numbness at HRQOL (27% vs 8%, p<0.001 at 3 years; 24% vs 9%, p=0.002 at 5 years). Until 3 years, more patients who had chemoradiotherapy reported limb weakness (21% vs 5%, p<0.001) and lower physical (79 vs 87, p<0.001) and role functioning (78 vs 88, p<0.001) scores. Both treatment groups reported similar long-term global health/QOL scores, which were better than those of the normative-population. Conclusion: This study shows a long-lasting, clinically relevant, negative impact of chemoradiotherapy on toxicity and HRQOL, most importantly persistent peripheral sensory neuropathy. Physical and role functioning impairments were seen until 3 years. These long-term data are essential for patient information and
- Published
- 2021
7. Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial
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MS Radiotherapie, Cancer, Post, Cathalijne C.B., de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke (P ).B., Ledermann, Jonathan A., Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy C.H.W., Brooks, Susan, Jürgenliemk-Schulz, Ina M., Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A., McCormack, Mary, Nout, Remi A., Verhoeven-Adema, Karen W., Smit, Vincent T.H.B.M., Putter, Hein, Creutzberg, Carien L., MS Radiotherapie, Cancer, Post, Cathalijne C.B., de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke (P ).B., Ledermann, Jonathan A., Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy C.H.W., Brooks, Susan, Jürgenliemk-Schulz, Ina M., Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A., McCormack, Mary, Nout, Remi A., Verhoeven-Adema, Karen W., Smit, Vincent T.H.B.M., Putter, Hein, and Creutzberg, Carien L.
- Published
- 2021
8. PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer
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van den Heerik, Anne Sophie V M, primary, Horeweg, Nanda, additional, Nout, Remi A, additional, Lutgens, Ludy C H W, additional, van der Steen-Banasik, Elzbieta M, additional, Westerveld, G Henrike, additional, van den Berg, Hetty A, additional, Slot, Annerie, additional, Koppe, Friederike L A, additional, Kommoss, Stefan, additional, Mens, Jan Willem M, additional, Nowee, Marlies E, additional, Bijmolt, Stefan, additional, Cibula, David, additional, Stam, Tanja C, additional, Jurgenliemk-Schulz, Ina M, additional, Snyers, An, additional, Hamann, Moritz, additional, Zwanenburg, Aleida G, additional, Coen, Veronique L M A, additional, Vandecasteele, Katrien, additional, Gillham, Charles, additional, Chargari, Cyrus, additional, Verhoeven-Adema, Karen W, additional, Putter, Hein, additional, van den Hout, Wilbert B, additional, Wortman, Bastiaan G, additional, Nijman, Hans W, additional, Bosse, Tjalling, additional, and Creutzberg, Carien L, additional
- Published
- 2020
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9. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : final results of an international, open-label, multicentre, randomised, phase 3 trial
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de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B., Ledermann, Jonathan A., Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie Helene, Jürgenliemk-Schulz, Ina M., Kitchener, Henry C., Nijman, Hans W., Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, Hanzen, Chantal, Lutgens, Ludy C.H.W., Smit, Vincent T.H.B.M., Singh, Naveena, Do, Viet, D'Amico, Romerai, Nout, Remi A., Feeney, Amanda, Verhoeven-Adema, Karen W., Putter, Hein, Creutzberg, Carien L., McCormack, Mary, Whitmarsh, Karen, Allerton, Rozenn, Gregory, Deborah, Symonds, Paul, Hoskin, Peter J., Adusumalli, Madhavi, Anand, Anjana, Wade, Robert, Stewart, Alexandra, Taylor, Wendy, Kruitwagen, Roy F.P.M., Hollema, Harry, Pras, Elizabeth, Snyers, An, Stalpers, Lukas, Jobsen, Jan J., Slot, Annerie, Mens, Jan Willem M., and Stam, Tanja C.
- Subjects
Canada ,Time Factors ,Endometrial Neoplasms/mortality ,Clinical Trial, Phase III ,Risk Factors ,Paclitaxel/administration & dosage ,Journal Article ,Humans ,Comparative Study ,Aged ,Neoplasm Staging ,Gynecologic Surgical Procedures/adverse effects ,Antineoplastic Combined Chemotherapy Protocols/adverse effects ,Research Support, Non-U.S. Gov't ,Australia ,Carboplatin/administration & dosage ,Chemoradiotherapy, Adjuvant/adverse effects ,Middle Aged ,Europe ,Multicenter Study ,Treatment Outcome ,Oncology ,Randomized Controlled Trial ,Carcinoma, Endometrioid/mortality ,Lymph Node Excision ,Female ,Radiotherapy, Adjuvant ,Dose Fractionation, Radiation ,Neoplasm Grading ,Cisplatin/administration & dosage ,New Zealand - Abstract
BACKGROUND: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer. METHODS: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup. Eligible women had high-risk endometrial cancer with FIGO 2009 stage I, endometrioid-type grade 3 with deep myometrial invasion or lymph-vascular space invasion (or both), endometrioid-type stage II or III, or stage I to III with serous or clear cell histology. Women were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or radiotherapy and chemotherapy (consisting of two cycles of cisplatin 50 mg/m 2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m 2) using a biased-coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The co-primary endpoints were overall survival and failure-free survival. We used the Kaplan-Meier method, log-rank test, and Cox regression analysis for final analysis by intention to treat and adjusted for stratification factors. The study was closed on Dec 20, 2013, after achieving complete accrual; follow-up is ongoing. PORTEC-3 is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. RESULTS: 686 women were enrolled between Nov 23, 2006, and Dec 20, 2013. 660 eligible patients were included in the final analysis, of whom 330 were assigned to chemoradiotherapy and 330 were assigned to radiotherapy. Median follow-up was 60·2 months (IQR 48·1-73·1). 5-year overall survival was 81·8% (95% CI 77·5-86·2) with chemoradiotherapy versus 76·7% (72·1-81·6) with radiotherapy (adjusted hazard ratio [HR] 0·76, 95% CI 0·54-1·06; p=0·11); 5-year failure-free survival was 75·5% (95% CI 70·3-79·9) versus 68·6% (63·1-73·4; HR 0·71, 95% CI 0·53-0·95; p=0·022). Grade 3 or worse adverse events during treatment occurred in 198 (60%) of 330 who received chemoradiotherapy versus 41 (12%) of 330 patients who received radiotherapy (p
- Published
- 2018
10. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial
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de Boer, Stephanie M, primary, Powell, Melanie E, additional, Mileshkin, Linda, additional, Katsaros, Dionyssios, additional, Bessette, Paul, additional, Haie-Meder, Christine, additional, Ottevanger, Petronella B, additional, Ledermann, Jonathan A, additional, Khaw, Pearly, additional, D'Amico, Romerai, additional, Fyles, Anthony, additional, Baron, Marie-Helene, additional, Jürgenliemk-Schulz, Ina M, additional, Kitchener, Henry C, additional, Nijman, Hans W, additional, Wilson, Godfrey, additional, Brooks, Susan, additional, Gribaudo, Sergio, additional, Provencher, Diane, additional, Hanzen, Chantal, additional, Kruitwagen, Roy F, additional, Smit, Vincent T H B M, additional, Singh, Naveena, additional, Do, Viet, additional, Lissoni, Andrea, additional, Nout, Remi A, additional, Feeney, Amanda, additional, Verhoeven-Adema, Karen W, additional, Putter, Hein, additional, Creutzberg, Carien L, additional, McCormack, M, additional, Whitmarsh, K, additional, Allerton, R, additional, Gregory, D, additional, Symonds, P, additional, Hoskin, PJ, additional, Adusumalli, M, additional, Anand, A, additional, Wade, R, additional, Stewart, A, additional, Taylor, W, additional, Lutgens, LCHW, additional, Hollema, H, additional, Pras, E, additional, Snyers, A, additional, Westerveld, GH, additional, Jobsen, JJ, additional, Slot, A, additional, Mens, JM, additional, Stam, TC, additional, Van Triest, B, additional, Van der Steen-Banasik, EM, additional, De Winter, KAJ, additional, Quinn, MA, additional, Kolodziej, I, additional, Pyman, J, additional, Johnson, C, additional, Capp, A, additional, Fossati, R, additional, Colombo, A, additional, Carinelli, S, additional, Ferrero, A, additional, Artioli, G, additional, Davidson, C, additional, McLachlin, CM, additional, Ghatage, P, additional, Rittenberg, PVC, additional, Souhami, L, additional, Thomas, G, additional, Duvillard, P, additional, Berton-Rigaud, D, additional, and Tubiana-Mathieu, N, additional
- Published
- 2019
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11. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial
- Author
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MS Radiotherapie, Cancer, de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B., Ledermann, Jonathan A., Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie Helene, Jürgenliemk-Schulz, Ina M., Kitchener, Henry C., Nijman, Hans W., Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, Hanzen, Chantal, Lutgens, Ludy C.H.W., Smit, Vincent T.H.B.M., Singh, Naveena, Do, Viet, D'Amico, Romerai, Nout, Remi A., Feeney, Amanda, Verhoeven-Adema, Karen W., Putter, Hein, Creutzberg, Carien L., McCormack, Mary, Whitmarsh, Karen, Allerton, Rozenn, Gregory, Deborah, Symonds, Paul, Hoskin, Peter J., Adusumalli, Madhavi, Anand, Anjana, Wade, Robert, Stewart, Alexandra, Taylor, Wendy, Kruitwagen, Roy F.P.M., Hollema, Harry, Pras, Elizabeth, Snyers, An, Stalpers, Lukas, Jobsen, Jan J., Slot, Annerie, Mens, Jan Willem M., Stam, Tanja C., PORTEC study group, MS Radiotherapie, Cancer, de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B., Ledermann, Jonathan A., Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie Helene, Jürgenliemk-Schulz, Ina M., Kitchener, Henry C., Nijman, Hans W., Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, Hanzen, Chantal, Lutgens, Ludy C.H.W., Smit, Vincent T.H.B.M., Singh, Naveena, Do, Viet, D'Amico, Romerai, Nout, Remi A., Feeney, Amanda, Verhoeven-Adema, Karen W., Putter, Hein, Creutzberg, Carien L., McCormack, Mary, Whitmarsh, Karen, Allerton, Rozenn, Gregory, Deborah, Symonds, Paul, Hoskin, Peter J., Adusumalli, Madhavi, Anand, Anjana, Wade, Robert, Stewart, Alexandra, Taylor, Wendy, Kruitwagen, Roy F.P.M., Hollema, Harry, Pras, Elizabeth, Snyers, An, Stalpers, Lukas, Jobsen, Jan J., Slot, Annerie, Mens, Jan Willem M., Stam, Tanja C., and PORTEC study group
- Published
- 2018
12. Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship: Results from the randomized PORTEC-2 trial
- Author
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MS Radiotherapie, Cancer, De Boer, Stephanie M., Nout, Remi A., Jurgenliemk-Schulz, Ina M., Jobsen, Jan J, Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Mens, Jan Willem M., Slot, Annerie, Stenfert Kroese, Marika C., Oerlemans, Simone, Putter, Hein, Verhoeven-Adema, Karen W., Nijman, Hans W, Creutzberg, Carien L., MS Radiotherapie, Cancer, De Boer, Stephanie M., Nout, Remi A., Jurgenliemk-Schulz, Ina M., Jobsen, Jan J, Lutgens, Ludy C.H.W., Van Der Steen-Banasik, Elzbieta M., Mens, Jan Willem M., Slot, Annerie, Stenfert Kroese, Marika C., Oerlemans, Simone, Putter, Hein, Verhoeven-Adema, Karen W., Nijman, Hans W, and Creutzberg, Carien L.
- Published
- 2015
13. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial.
- Author
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de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, and Creutzberg CL
- Subjects
- Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Australia, Canada, Carboplatin administration & dosage, Carcinoma, Endometrioid mortality, Carcinoma, Endometrioid pathology, Cisplatin administration & dosage, Endometrial Neoplasms mortality, Endometrial Neoplasms pathology, Europe, Female, Humans, Lymph Node Excision, Middle Aged, Neoplasm Grading, Neoplasm Staging, New Zealand, Paclitaxel administration & dosage, Radiotherapy, Adjuvant, Risk Factors, Time Factors, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Endometrioid radiotherapy, Carcinoma, Endometrioid therapy, Chemoradiotherapy, Adjuvant adverse effects, Chemoradiotherapy, Adjuvant mortality, Dose Fractionation, Radiation, Endometrial Neoplasms therapy, Gynecologic Surgical Procedures adverse effects, Gynecologic Surgical Procedures mortality
- Abstract
Background: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer., Methods: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup. Eligible women had high-risk endometrial cancer with FIGO 2009 stage I, endometrioid-type grade 3 with deep myometrial invasion or lymph-vascular space invasion (or both), endometrioid-type stage II or III, or stage I to III with serous or clear cell histology. Women were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or radiotherapy and chemotherapy (consisting of two cycles of cisplatin 50 mg/m
2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2 ) using a biased-coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The co-primary endpoints were overall survival and failure-free survival. We used the Kaplan-Meier method, log-rank test, and Cox regression analysis for final analysis by intention to treat and adjusted for stratification factors. The study was closed on Dec 20, 2013, after achieving complete accrual; follow-up is ongoing. PORTEC-3 is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138., Results: 686 women were enrolled between Nov 23, 2006, and Dec 20, 2013. 660 eligible patients were included in the final analysis, of whom 330 were assigned to chemoradiotherapy and 330 were assigned to radiotherapy. Median follow-up was 60·2 months (IQR 48·1-73·1). 5-year overall survival was 81·8% (95% CI 77·5-86·2) with chemoradiotherapy versus 76·7% (72·1-81·6) with radiotherapy (adjusted hazard ratio [HR] 0·76, 95% CI 0·54-1·06; p=0·11); 5-year failure-free survival was 75·5% (95% CI 70·3-79·9) versus 68·6% (63·1-73·4; HR 0·71, 95% CI 0·53-0·95; p=0·022). Grade 3 or worse adverse events during treatment occurred in 198 (60%) of 330 who received chemoradiotherapy versus 41 (12%) of 330 patients who received radiotherapy (p<0·0001). Neuropathy (grade 2 or worse) persisted significantly more often after chemoradiotherapy than after radiotherapy (20 [8%] women vs one [1%] at 3 years; p<0·0001). Most deaths were due to endometrial cancer; in four patients (two in each group), the cause of death was uncertain. One death in the radiotherapy group was due to either disease progression or late treatment complications; three deaths (two in the chemoradiotherapy group and one in the radiotherapy group) were due to either intercurrent disease or late treatment-related toxicity., Interpretation: Adjuvant chemotherapy given during and after radiotherapy for high-risk endometrial cancer did not improve 5-year overall survival, although it did increase failure-free survival. Women with high-risk endometrial cancer should be individually counselled about this combined treatment. Continued follow-up is needed to evaluate long-term survival., Funding: Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council Project Grant and Cancer Australia, L'Agenzia Italiana del Farmaco, and Canadian Cancer Society Research Institute., (Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC-BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2018
- Full Text
- View/download PDF
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