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1. Clinical evaluation of a low-coverage whole-genome test for detecting homologous recombination deficiency in ovarian cancer

Author

Boidot, R, Blum, M, Wissler, M, Gottin, C, Ruzicka, J, Chevrier, S, Delhomme, T, Audoux, J, Jeanniard, A, Just, P, Harter, P, Pignata, S, Gonzalez-Martin, A, Marth, C, Maenpaa, J, Colombo, N, Vergote, I, Fujiwara, K, Duforet-Frebourg, N, Bertrand, D, Philippe, N, Ray-Coquard, I, Pujade-Lauraine, E, Boidot R., Blum M. G. B., Wissler M. -P., Gottin C., Ruzicka J., Chevrier S., Delhomme T. M., Audoux J., Jeanniard A., Just P. -A., Harter P., Pignata S., Gonzalez-Martin A., Marth C., Maenpaa J., Colombo N., Vergote I., Fujiwara K., Duforet-Frebourg N., Bertrand D., Philippe N., Ray-Coquard I., Pujade-Lauraine E., Boidot, R, Blum, M, Wissler, M, Gottin, C, Ruzicka, J, Chevrier, S, Delhomme, T, Audoux, J, Jeanniard, A, Just, P, Harter, P, Pignata, S, Gonzalez-Martin, A, Marth, C, Maenpaa, J, Colombo, N, Vergote, I, Fujiwara, K, Duforet-Frebourg, N, Bertrand, D, Philippe, N, Ray-Coquard, I, Pujade-Lauraine, E, Boidot R., Blum M. G. B., Wissler M. -P., Gottin C., Ruzicka J., Chevrier S., Delhomme T. M., Audoux J., Jeanniard A., Just P. -A., Harter P., Pignata S., Gonzalez-Martin A., Marth C., Maenpaa J., Colombo N., Vergote I., Fujiwara K., Duforet-Frebourg N., Bertrand D., Philippe N., Ray-Coquard I., and Pujade-Lauraine E.

Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed that maintenance olaparib plus bevacizumab increases survival of advanced ovarian cancer patients with homologous recombination deficiency (HRD). However, decentralized solutions to test for HRD in clinical routine are scarce. The goal of this study was to retrospectively validate on tumor samples from the PAOLA-1 trial, the decentralized SeqOne assay, which relies on shallow Whole Genome Sequencing (sWGS) to capture genomic instability and targeted sequencing to determine BRCA status. Methods: The study comprised 368 patients from the PAOLA-1 trial. The SeqOne assay was compared to the Myriad MyChoice HRD test (Myriad Genetics), and results were analyzed with respect to Progression-Free Survival (PFS). Results: We found a 95% concordance between the HRD status of the two tests (95% Confidence Interval (CI); 92%−97%). The Positive Percentage Agreement (PPA) of the sWGS test was 95% (95% CI; 91%−97%) like its Negative Percentage Agreement (NPA) (95% CI; 89%−98%). In patients with HRD-positive tumors treated with olaparib plus bevacizumab, the PFS Hazard Ratio (HR) was 0.38 (95% CI; 0.26–0.54) with SeqOne assay and 0.32 (95% CI; 0.22–0.45) with the Myriad assay. In patients with HRD-negative tumors, HR was 0.99 (95% CI; 0.68–1.42) and 1.05 (95% CI; 0.70–1.57) with SeqOne and Myriad assays. Among patients with BRCA-wildtype tumors, those with HRD-positive tumors, benefited from olaparib plus bevacizumab maintenance, with HR of 0.48 (95% CI: 0.29–0.79) and of 0.38 (95% CI: 0.23 to 0.63) with the SeqOne and Myriad assay. Conclusion: The SeqOne assay offers a clinically validated approach to detect HRD.

Published
2024

2. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer

Author

Vergote, I., Ausems, M., Brasiuniene, B., Brenton, J., Büttner, R., Colombo, N., González-Martín, A., Harter, P., Lambrechts, D., Lorusso, D., Madry, R., Mirza, M.R., Pujol, P., Ray-Coquard, I., Abreu, M., Balboni, S., Banerjee, S., Barberis, M., Barretina Ginesta, M.P., Baurain, J.-F., Bignami, M., Bjorge, L., Blecharz, P., Bruchim, I., Capilna, M., Cerana, N., Cicchetti, A., Collins, D., Concin, N., D’Incalci, M., Davidson, B., de la Motte Rouge, T., De Iaco, P., Demirkiran, F., Denys, H., Doerk, T., Dorum, A., Ferrero, A., Fidalgo, A.P., Genuardi, M., Gladieff, L., Glasspool, R., Grimm, C., Gultekin, M., Hahnen, E., Hasenburg, A., Hegmane, A., Heinzelmann, V., Hogdall, E., Janavicius, R., Jarmalaite, S., Kalachand, R., Kaneva, R., Kilickap, S., Kocian, R., Kolencik, D., Kristeleit, R., Kryzhanivska, A., Leary, A., Lemley, B., Ligtenberg, M., López-Guerrero, J.A., Lord, C.J., Avall-Lundqvist, E., Maenpaa, J., Mahner, S., Marmé, F., Marth, C., McNeish, I., Merkelbach-Bruse, S., Mourits, M., Normanno, N., Oaknin, A., Ojamaa, K., Papdimitriou, C., Penault-Llorca, F., Perrone, A.M., Pignata, S., Pikarsky, E., Rouleau, E., Rubio, M., Sapino, A., Schmalfeldt, B., Sehouli, J., Shapira, R., Steffensen, K.D., Sukhin, V., Syrios, J., Szallasi, Z., Taskiran, C., Terzic, M., Tischkowitz, M., Toth, I., Van de Vijver, K., Vardar, M.A., Wasag, B., Wimberger, P., Witteveen, E., Brenton, J.D., and Ausems, M.G.E.M.

Published
2022
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4. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer

Author

Vergote, I, Gonzalez-Martin, A, Ray-Coquard, I, Harter, P, Colombo, N, Pujol, P, Lorusso, D, Mirza, M, Brasiuniene, B, Madry, R, Brenton, J, Ausems, M, Buttner, R, Lambrechts, D, Abreu, M, Balboni, S, Banerjee, S, Barberis, M, Barretina Ginesta, M, Baurain, J, Bignami, M, Bjorge, L, Blecharz, P, Bruchim, I, Capilna, M, Cerana, N, Cicchetti, A, Collins, D, Concin, N, D'Incalci, M, Davidson, B, de la Motte Rouge, T, De Iaco, P, Demirkiran, F, Denys, H, Doerk, T, Dorum, A, Ferrero, A, Fidalgo, A, Genuardi, M, Gladieff, L, Glasspool, R, Grimm, C, Gultekin, M, Hahnen, E, Hasenburg, A, Hegmane, A, Heinzelmann, V, Hogdall, E, Janavicius, R, Jarmalaite, S, Kalachand, R, Kaneva, R, Kilickap, S, Kocian, R, Kolencik, D, Kristeleit, R, Kryzhanivska, A, Leary, A, Lemley, B, Ligtenberg, M, Lopez-Guerrero, J, Lord, C, Avall-Lundqvist, E, Maenpaa, J, Mahner, S, Marme, F, Marth, C, Mcneish, I, Merkelbach-Bruse, S, Mourits, M, Normanno, N, Oaknin, A, Ojamaa, K, Papdimitriou, C, Penault-Llorca, F, Perrone, A, Pignata, S, Pikarsky, E, Rouleau, E, Rubio, M, Sapino, A, Schmalfeldt, B, Sehouli, J, Shapira, R, Steffensen, K, Sukhin, V, Syrios, J, Szallasi, Z, Taskiran, C, Terzic, M, Tischkowitz, M, Toth, I, Van de Vijver, K, Vardar, M, Wasag, B, Wimberger, P, Witteveen, E, Vergote I., Gonzalez-Martin A., Ray-Coquard I., Harter P., Colombo N., Pujol P., Lorusso D., Mirza M. R., Brasiuniene B., Madry R., Brenton J. D., Ausems M. G. E. M., Buttner R., Lambrechts D., Ausems M., Brenton J., Abreu M., Balboni S., Banerjee S., Barberis M., Barretina Ginesta M. P., Baurain J. -F., Bignami M., Bjorge L., Blecharz P., Bruchim I., Capilna M., Cerana N., Cicchetti A., Collins D., Concin N., D'Incalci M., Davidson B., de la Motte Rouge T., De Iaco P., Demirkiran F., Denys H., Doerk T., Dorum A., Ferrero A., Fidalgo A. P., Genuardi M., Gladieff L., Glasspool R., Grimm C., Gultekin M., Hahnen E., Hasenburg A., Hegmane A., Heinzelmann V., Hogdall E., Janavicius R., Jarmalaite S., Kalachand R., Kaneva R., Kilickap S., Kocian R., Kolencik D., Kristeleit R., Kryzhanivska A., Leary A., Lemley B., Ligtenberg M., Lopez-Guerrero J. A., Lord C. J., Avall-Lundqvist E., Maenpaa J., Mahner S., Marme F., Marth C., McNeish I., Merkelbach-Bruse S., Mourits M., Normanno N., Oaknin A., Ojamaa K., Papdimitriou C., Penault-Llorca F., Perrone A. M., Pignata S., Pikarsky E., Rouleau E., Rubio M., Sapino A., Schmalfeldt B., Sehouli J., Shapira R., Steffensen K. D., Sukhin V., Syrios J., Szallasi Z., Taskiran C., Terzic M., Tischkowitz M., Toth I., Van de Vijver K., Vardar M. A., Wasag B., Wimberger P., Witteveen E., Vergote, I, Gonzalez-Martin, A, Ray-Coquard, I, Harter, P, Colombo, N, Pujol, P, Lorusso, D, Mirza, M, Brasiuniene, B, Madry, R, Brenton, J, Ausems, M, Buttner, R, Lambrechts, D, Abreu, M, Balboni, S, Banerjee, S, Barberis, M, Barretina Ginesta, M, Baurain, J, Bignami, M, Bjorge, L, Blecharz, P, Bruchim, I, Capilna, M, Cerana, N, Cicchetti, A, Collins, D, Concin, N, D'Incalci, M, Davidson, B, de la Motte Rouge, T, De Iaco, P, Demirkiran, F, Denys, H, Doerk, T, Dorum, A, Ferrero, A, Fidalgo, A, Genuardi, M, Gladieff, L, Glasspool, R, Grimm, C, Gultekin, M, Hahnen, E, Hasenburg, A, Hegmane, A, Heinzelmann, V, Hogdall, E, Janavicius, R, Jarmalaite, S, Kalachand, R, Kaneva, R, Kilickap, S, Kocian, R, Kolencik, D, Kristeleit, R, Kryzhanivska, A, Leary, A, Lemley, B, Ligtenberg, M, Lopez-Guerrero, J, Lord, C, Avall-Lundqvist, E, Maenpaa, J, Mahner, S, Marme, F, Marth, C, Mcneish, I, Merkelbach-Bruse, S, Mourits, M, Normanno, N, Oaknin, A, Ojamaa, K, Papdimitriou, C, Penault-Llorca, F, Perrone, A, Pignata, S, Pikarsky, E, Rouleau, E, Rubio, M, Sapino, A, Schmalfeldt, B, Sehouli, J, Shapira, R, Steffensen, K, Sukhin, V, Syrios, J, Szallasi, Z, Taskiran, C, Terzic, M, Tischkowitz, M, Toth, I, Van de Vijver, K, Vardar, M, Wasag, B, Wimberger, P, Witteveen, E, Vergote I., Gonzalez-Martin A., Ray-Coquard I., Harter P., Colombo N., Pujol P., Lorusso D., Mirza M. R., Brasiuniene B., Madry R., Brenton J. D., Ausems M. G. E. M., Buttner R., Lambrechts D., Ausems M., Brenton J., Abreu M., Balboni S., Banerjee S., Barberis M., Barretina Ginesta M. P., Baurain J. -F., Bignami M., Bjorge L., Blecharz P., Bruchim I., Capilna M., Cerana N., Cicchetti A., Collins D., Concin N., D'Incalci M., Davidson B., de la Motte Rouge T., De Iaco P., Demirkiran F., Denys H., Doerk T., Dorum A., Ferrero A., Fidalgo A. P., Genuardi M., Gladieff L., Glasspool R., Grimm C., Gultekin M., Hahnen E., Hasenburg A., Hegmane A., Heinzelmann V., Hogdall E., Janavicius R., Jarmalaite S., Kalachand R., Kaneva R., Kilickap S., Kocian R., Kolencik D., Kristeleit R., Kryzhanivska A., Leary A., Lemley B., Ligtenberg M., Lopez-Guerrero J. A., Lord C. J., Avall-Lundqvist E., Maenpaa J., Mahner S., Marme F., Marth C., McNeish I., Merkelbach-Bruse S., Mourits M., Normanno N., Oaknin A., Ojamaa K., Papdimitriou C., Penault-Llorca F., Perrone A. M., Pignata S., Pikarsky E., Rouleau E., Rubio M., Sapino A., Schmalfeldt B., Sehouli J., Shapira R., Steffensen K. D., Sukhin V., Syrios J., Szallasi Z., Taskiran C., Terzic M., Tischkowitz M., Toth I., Van de Vijver K., Vardar M. A., Wasag B., Wimberger P., and Witteveen E.

Abstract

Background: Homologous recombination repair (HRR) enables fault-free repair of double-stranded DNA breaks. HRR deficiency is predicted to occur in around half of high-grade serous ovarian carcinomas. Ovarian cancers harbouring HRR deficiency typically exhibit sensitivity to poly-ADP ribose polymerase inhibitors (PARPi). Current guidelines recommend a range of approaches for genetic testing to identify predictors of sensitivity to PARPi in ovarian cancer and to identify genetic predisposition. Design: To establish a European-wide consensus for genetic testing (including the genetic care pathway), decision making and clinical management of patients with recently diagnosed advanced ovarian cancer, and the validity of biomarkers to predict the effectiveness of PARPi in the first-line setting. The collaborative European experts’ consensus group consisted of a steering committee (n = 14) and contributors (n = 84). A (modified) Delphi process was used to establish consensus statements based on a systematic literature search, conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Results: A consensus was reached on 34 statements amongst 98 caregivers (including oncologists, pathologists, clinical geneticists, genetic researchers, and patient advocates). The statements concentrated on (i) the value of testing for BRCA1/2 mutations and HRR deficiency testing, including when and whom to test; (ii) the importance of developing new and better HRR deficiency tests; (iii) the importance of germline non-BRCA HRR and mismatch repair gene mutations for predicting familial risk, but not for predicting sensitivity to PARPi, in the first-line setting; (iv) who should be able to inform patients about genetic testing, and what training and education should these caregivers receive. Conclusion: These consensus recommendations, from a multidisciplinary panel of experts from across Europe, provide clear guidance on the use of BRCA and HRR de

Published
2022

5. 176O Final overall survival (OS) results from the phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

Author

Nagao, S., primary, Harter, P., additional, Leary, A., additional, Cropet, C., additional, Pignata, S., additional, Fujiwara, K., additional, Gonzalez Martin, A.J., additional, Bogner, G., additional, Vergote, I., additional, Colombo, N., additional, Maenpaa, J., additional, Selle, F., additional, Schmalfeldt, B., additional, Scambia, G., additional, Guerra Alia, E.M., additional, Lefeuvre-Plesse, C., additional, Belau, A., additional, Lortholary, A., additional, Gropp-Meier, M., additional, Pujade-Lauraine, E., additional, and Ray-Coquard, I., additional

Published
2022
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6. Population-adjusted indirect treatment comparison of the SOLO1 and PAOLA-1/ENGOT-ov25 trials evaluating maintenance olaparib or bevacizumab or the combination of both in newly diagnosed, advanced BRCA-mutated ovarian cancer

Author

Vergote, I, Ray-Coquard, I, Anderson, D, Cantuaria, G, Colombo, N, Garnier-Tixidre, C, Gilbert, L, Harter, P, Hettle, R, Lorusso, D, Maenpaa, J, Marth, C, Matsumoto, K, Ouwens, M, Poveda, A, Raspagliesi, F, Rhodes, K, Rubio Perez, M, Shapira-Frommer, R, Shikama, A, Sikorska, M, Moore, K, Disilvestro, P, Vergote I., Ray-Coquard I., Anderson D. M., Cantuaria G., Colombo N., Garnier-Tixidre C., Gilbert L., Harter P., Hettle R., Lorusso D., Maenpaa J., Marth C., Matsumoto K., Ouwens M., Poveda A., Raspagliesi F., Rhodes K., Rubio Perez M. J., Shapira-Frommer R., Shikama A., Sikorska M., Moore K., DiSilvestro P., Vergote, I, Ray-Coquard, I, Anderson, D, Cantuaria, G, Colombo, N, Garnier-Tixidre, C, Gilbert, L, Harter, P, Hettle, R, Lorusso, D, Maenpaa, J, Marth, C, Matsumoto, K, Ouwens, M, Poveda, A, Raspagliesi, F, Rhodes, K, Rubio Perez, M, Shapira-Frommer, R, Shikama, A, Sikorska, M, Moore, K, Disilvestro, P, Vergote I., Ray-Coquard I., Anderson D. M., Cantuaria G., Colombo N., Garnier-Tixidre C., Gilbert L., Harter P., Hettle R., Lorusso D., Maenpaa J., Marth C., Matsumoto K., Ouwens M., Poveda A., Raspagliesi F., Rhodes K., Rubio Perez M. J., Shapira-Frommer R., Shikama A., Sikorska M., Moore K., and DiSilvestro P.

Abstract

Background: In the absence of randomised head-to-head trials, we conducted a population-adjusted indirect treatment comparison (PA-ITC) of phase III trial data to evaluate the relative efficacy and safety of maintenance olaparib and bevacizumab alone and in combination in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation (BRCAm). Methods: An unanchored PA-ITC was performed on investigator-assessed progression-free survival (PFS) data. Individual patient data from SOLO1 (olaparib versus placebo) and from BRCA-mutated patients in PAOLA-1/ENGOT-ov25 (olaparib plus bevacizumab versus placebo plus bevacizumab) were pooled. Each arm of PAOLA-1 was weighted so that key baseline patient characteristics were similar to the SOLO1 cohort. Analyses were performed in patients with complete baseline data. Weighted Cox regression analysis was used to estimate the comparative efficacy of different maintenance therapy strategies, supplemented by weighted Kaplan–Meier analyses. Results: Data from SOLO1 patients (olaparib, n = 254; placebo, n = 126) were compared with data from BRCA-mutated PAOLA-1 patients (olaparib plus bevacizumab, n = 151; placebo plus bevacizumab, n = 71). Adding bevacizumab to olaparib was associated with a numerical improvement in PFS compared with olaparib alone (hazard ratio [HR] 0.71; 95% confidence interval [CI] 0.45–1.09). Statistically significant improvements in PFS were seen with olaparib alone versus placebo plus bevacizumab (HR 0.48; 95% CI 0.30–0.75), olaparib plus bevacizumab versus placebo (0.23; 0.14–0.34), and placebo plus bevacizumab versus placebo (0.65; 0.43–0.95). Conclusions: Results of this hypothesis-generating PA-ITC analysis support the use of maintenance olaparib alone or with bevacizumab in patients with newly diagnosed, advanced ovarian cancer and a BRCAm.

Published
2021

7. Atezolizumab, bevacizumab, and chemotherapy for newly diagnosed stage III or IV ovarian cancer: Placebo-controlled randomized phase III trial (IMagyn050/GOG 3015/ENGOT-OV39)

Author

Moore, K, Bookman, M, Sehouli, J, Miller, A, Anderson, C, Scambia, G, Myers, T, Taskiran, C, Robison, K, Maenpaa, J, Willmott, L, Colombo, N, Thomes-Pepin, J, Liontos, M, Gold, M, Garcia, Y, Sharma, S, Darus, C, Aghajanian, C, Okamoto, A, Wu, X, Safin, R, Wu, F, Molinero, L, Maiya, V, Khor, V, Lin, Y, Pignata, S, Moore K. N., Bookman M., Sehouli J., Miller A., Anderson C., Scambia G., Myers T., Taskiran C., Robison K., Maenpaa J., Willmott L., Colombo N., Thomes-Pepin J., Liontos M., Gold M. A., Garcia Y., Sharma S. K., Darus C. J., Aghajanian C., Okamoto A., Wu X., Safin R., Wu F., Molinero L., Maiya V., Khor V. K., Lin Y. G., Pignata S., Moore, K, Bookman, M, Sehouli, J, Miller, A, Anderson, C, Scambia, G, Myers, T, Taskiran, C, Robison, K, Maenpaa, J, Willmott, L, Colombo, N, Thomes-Pepin, J, Liontos, M, Gold, M, Garcia, Y, Sharma, S, Darus, C, Aghajanian, C, Okamoto, A, Wu, X, Safin, R, Wu, F, Molinero, L, Maiya, V, Khor, V, Lin, Y, Pignata, S, Moore K. N., Bookman M., Sehouli J., Miller A., Anderson C., Scambia G., Myers T., Taskiran C., Robison K., Maenpaa J., Willmott L., Colombo N., Thomes-Pepin J., Liontos M., Gold M. A., Garcia Y., Sharma S. K., Darus C. J., Aghajanian C., Okamoto A., Wu X., Safin R., Wu F., Molinero L., Maiya V., Khor V. K., Lin Y. G., and Pignata S.

Abstract

PURPOSE To evaluate the addition of the humanized monoclonal antiprogrammed death ligand-1 (PD-L1) antibody, atezolizumab, to platinum-based chemotherapy and bevacizumab in newly diagnosed stage III or IV ovarian cancer (OC). METHODS This multicenter placebo-controlled double-blind randomized phase III trial (ClinicalTrials.gov identifier: NCT03038100) enrolled patients with newly diagnosed untreated International Federation of Gynecology and Obstetrics (FIGO) stage III or IV OC who either had undergone primary cytoreductive surgery with macroscopic residual disease or were planned to receive neoadjuvant chemotherapy and interval surgery. Patients were stratified by FIGO stage, Eastern Cooperative Oncology Group performance status, tumor immune cell PD-L1 staining, and treatment strategy and randomly assigned 1:1 to receive 3-weekly cycles of atezolizumab 1,200 mg or placebo (day 1, cycles 1-22), with paclitaxel plus carboplatin (day 1, cycles 1-6) plus bevacizumab 15 mg/kg (day 1, cycles 2-22), omitting perioperative bevacizumab in neoadjuvant patients. The co-primary end points were investigator-assessed progression-free survival and overall survival in the intention-to-treat and PD-L1-positive populations. RESULTS Between March 8, 2017, and March 26, 2019, 1,301 patients were enrolled. The median progression-free survival was 19.5 versus 18.4 months with atezolizumab versus placebo, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.07; stratified log-rank P 5.28), in the intention-to-treat population and 20.8 versus 18.5 months, respectively (hazard ratio, 0.80; 95% CI, 0.65 to 0.99; P 5.038), in the PD-L1-positive population. The interim (immature) overall survival results showed no significant benefit from atezolizumab. The most common grade 3 or 4 adverse events were neutropenia (21% with atezolizumab v 21% with placebo), hypertension (18% v 20%, respectively), and anemia (12% v 12%). CONCLUSION Current evidence does not support the use of immune checkpoint

Published
2021

8. LBA29 Final overall survival (OS) results from the phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

Author

Ray-Coquard, I.L., primary, Leary, A., additional, Pignata, S., additional, Cropet, C., additional, Martin, A.J. Gonzalez, additional, Bogner, G., additional, Yoshida, H., additional, Vergote, I.B., additional, Colombo, N., additional, Maenpaa, J., additional, Selle, F., additional, Schmalfeldt, B., additional, Scambia, G., additional, Alia, E.M. Guerra, additional, Lefeuvre-Plesse, C., additional, Belau, A., additional, Lortholary, A., additional, Gropp-Meier, M., additional, Pujade-Lauraine, E., additional, and Harter, P., additional

Published
2022
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10. 1195 Results of NSGO-OV-UMB1/ENGOT-OV30 study: a phase II study of durvalumab and oleclumab in patients with relapsed ovarian cancer (OC)

Author

Mirza, M, primary, Henriksen, JR, additional, Maenpaa, J, additional, Depont Christensen, R, additional, Waldstroem, M, additional, Tandaric, L, additional, Lindemann, K, additional, Roed, H, additional, Auranen, A, additional, Akslen, L, additional, Magnusson, M, additional, Lindberg, S, additional, Madsen, K, additional, and Bjorge, L, additional

Published
2021
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11. 1196 A randomised phase II study of combination chemotherapy with nintedanib/placebo in advanced/recurrent endometrial cancer. FANDANGO/ENGOT-EN1/FANDANGO

Author

Mirza, M, primary, Berton, D, additional, Vergote, I, additional, Depont Christensen, R, additional, Floquet, A, additional, Maenpaa, J, additional, Braicu, I, additional, Altintas, S, additional, Follana, P, additional, Ør Knudsen, A, additional, Ataseven, B, additional, Selle, F, additional, Lundgren, C, additional, Huober, J, additional, Fabbro, M, additional, Denys, H, additional, Heudel, P, additional, Magnusson, M, additional, Lindemann, K, additional, and Sehouli, J, additional

Published
2021
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12. Concordance between Tumor and Germline BRCA Status in High-Grade Ovarian Carcinoma Patients in the Phase III PAOLA-1/ENGOT-ov25 Trial

Author

Callens, C, Vaur, D, Soubeyran, I, Rouleau, E, Just, P, Guillerm, E, Golmard, L, Goardon, N, Sevenet, N, Cabaret, O, Harter, P, Gonzalez-Martin, A, Fujiwara, K, Cecere, S, Colombo, N, Marth, C, Vergote, I, Maenpaa, J, Pujade-Lauraine, E, Ray-Coquard, I, Callens, Céline, Vaur, Dominique, Soubeyran, Isabelle, Rouleau, Etienne, Just, Pierre-Alexandre, Guillerm, Erell, Golmard, Lisa, Goardon, Nicolas, Sevenet, Nicolas, Cabaret, Odile, Harter, Philipp, Gonzalez-Martin, Antonio, Fujiwara, Keiichi, Cecere, Sabrina Chiara, Colombo, Nicoletta, Marth, Christian, Vergote, Ignace, Maenpaa, Johanna, Pujade-Lauraine, Eric, Ray-Coquard, Isabelle, Callens, C, Vaur, D, Soubeyran, I, Rouleau, E, Just, P, Guillerm, E, Golmard, L, Goardon, N, Sevenet, N, Cabaret, O, Harter, P, Gonzalez-Martin, A, Fujiwara, K, Cecere, S, Colombo, N, Marth, C, Vergote, I, Maenpaa, J, Pujade-Lauraine, E, Ray-Coquard, I, Callens, Céline, Vaur, Dominique, Soubeyran, Isabelle, Rouleau, Etienne, Just, Pierre-Alexandre, Guillerm, Erell, Golmard, Lisa, Goardon, Nicolas, Sevenet, Nicolas, Cabaret, Odile, Harter, Philipp, Gonzalez-Martin, Antonio, Fujiwara, Keiichi, Cecere, Sabrina Chiara, Colombo, Nicoletta, Marth, Christian, Vergote, Ignace, Maenpaa, Johanna, Pujade-Lauraine, Eric, and Ray-Coquard, Isabelle

Abstract

BACKGROUND: PAOLA1 is a phase III study assessing olaparib maintenance therapy in advanced high-grade ovarian carcinoma patients responding to first-line platinum-taxane-based chemotherapy plus bevacizumab as standard of care. Randomization was stratified by treatment outcome and tumor BRCA1/2 status (tBRCA) at screening. METHODS: tBRCA was tested on formalin-fixed, paraffin-embedded tumor blocks on 5 French platforms using 2 next-generation sequencing methods based either on hybrid capture or amplicon technology. One of the exploratory objectives was to assess the concordance between germline (gBRCA) and tBRCA testing in French patients. gBRCA testing was performed on blood samples on the same platforms. RESULTS: From May 2015 to July 2017, tBRCA tests were performed for 1176 screened patients. Only 52 (4.4%) tumor samples were noncontributive. The median interval between reception of the tumor sample and availability of the tBRCA status result was 37 days (range = 8-260). A pathogenic variant was reported in 27.1% tumor samples (319 of 1176 screened patients). tBRCA and gBRCA testing were performed for 451 French patients with negative results for both tests in 306 patients (67.8%) and positive results for both tests in 85 patients (18.8%). Only 1 large genomic rearrangement of BRCA1 was detected, exclusively in the blood sample. Interestingly, tBRCA testing revealed 6.4% of pathogenic variant (29 of 451) not detected by gBRCA testing. CONCLUSIONS: tBRCA testing is an appropriate tool with an acceptable turnaround time for clinical practice and a low failure rate, ensuring reliable identification of patients likely to benefit from poly(ADP-ribose) polymerase inhibitor therapy.

Published
2021

13. INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author

Colombo, N., Gadducci, A., Sehouli, J., Biagioli, E., Nyvang, G-B., Riniker, S., Montes, A., Ottevanger, N., Zeimet, A. G. G., Vergote, I. B., Funari, G., Baldoni, A., Tognon, G., De Censi, A., Churruca Galaz, C., Chekerov, R., Maenpaa, J., Rulli, E., Fossati, R., and Poveda, A.

Published
2020
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14. 17 Safety and patient-reported outcomes in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Freyer, G, primary, Pothuri, B, additional, Han, S, additional, Chase, D, additional, Monk, B, additional, Heitz, F, additional, Burger, R, additional, Gaba, L, additional, Van Le, L, additional, Guerra, E, additional, Bender, D, additional, Korach, J, additional, Cloven, N, additional, Churruca, C, additional, Follana, P, additional, DiSilvestro, P, additional, Baurain, JF, additional, Jardon, K, additional, Pisano, C, additional, Peen, U, additional, Maenpaa, J, additional, Hoskins, P, additional, Bacque, E, additional, Li, Y, additional, Eliason, L, additional, and González-Martín, A, additional

Published
2020
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15. Patient-reported outcomes (PRO) in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Heitz, F, additional, Pothuri, B, additional, Han, S, additional, Chase, D, additional, Burger, R, additional, Gaba, L, additional, Van Le, L, additional, Guerra, E, additional, Bender, D, additional, Korach, J, additional, Cloven, N, additional, Follana, P, additional, Baurain, JF, additional, Pisano, C, additional, Peen, U, additional, Maenpaa, J, additional, Bacque, E, additional, Li, Y, additional, González-Martin, A, additional, and Monk, BJ, additional

Published
2020
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16. LBA33 Maintenance olaparib plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced high‐grade ovarian carcinoma (HGOC): Final analysis of second progression-free survival (PFS2) in the phase III PAOLA-1/ENGOT-ov25 trial

Author

Martín, A. González, primary, Tazi, Y., additional, Heitz, F., additional, Montane, L., additional, Gargiulo, P., additional, Berger, R., additional, Yonemori, K., additional, Vergote, I., additional, Bologna, A., additional, Maenpaa, J., additional, Costan, C., additional, Canzler, U., additional, Zamagni, C., additional, Guerra-Alia, E.M., additional, Levaché, C.B., additional, Marmé, F., additional, Kalbacher, E., additional, De Gregorio, N., additional, Dohollou, N., additional, and Ray-Coquard, I.L., additional

Published
2020
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17. 810MO Patient-reported outcomes (PROs) in patients (pts) receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Pothuri, B., primary, Han, S., additional, Chase, D., additional, Heitz, F., additional, Burger, R., additional, Gaba, L., additional, Van Le, L., additional, Guerra, E., additional, Bender, D., additional, Korach, J., additional, Cloven, N.G., additional, Follana, P., additional, Baurain, J-F., additional, Pisano, C., additional, Peen, U., additional, Maenpaa, J., additional, Bacqué, E., additional, Li, Y., additional, Martín, A. González, additional, and Monk, B.J., additional

Published
2020
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19. LBA30 INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Author

Colombo, N., primary, Gadducci, A., additional, Sehouli, J., additional, Biagioli, E., additional, Nyvang, G-B., additional, Riniker, S., additional, Montes, A., additional, Ottevanger, N., additional, Zeimet, A.G.G., additional, Vergote, I.B., additional, Funari, G., additional, Baldoni, A., additional, Tognon, G., additional, De Censi, A., additional, Galaz, C. Churruca, additional, Chekerov, R., additional, Maenpaa, J., additional, Rulli, E., additional, Fossati, R., additional, and Poveda, A., additional

Published
2020
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20. LBA31 Primary results from IMagyn050/GOG 3015/ENGOT-OV39, a double-blind placebo (pbo)-controlled randomised phase III trial of bevacizumab (bev)-containing therapy +/- atezolizumab (atezo) for newly diagnosed stage III/IV ovarian cancer (OC)

Author

Moore, K.N., primary, Bookman, M., additional, Sehouli, J., additional, Miller, A., additional, Anderson, C., additional, Scambia, G., additional, Myers, T., additional, Taskiran, C., additional, Robison, K., additional, Maenpaa, J., additional, Willmott, L.J., additional, Colombo, N., additional, Thomes-Pepin, J., additional, Gold, M.A., additional, Aghajanian, C., additional, Wu, F., additional, Molinero, L., additional, Khor, V., additional, Lin, Y.G., additional, and Pignata, S., additional

Published
2020
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21. Harmonising clinical trials within the Gynecologic Cancer InterGroup: Consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference

Author

Bookman, M, Okamoto, A, Stuart, G, Yanaihara, N, Aoki, D, Bacon, M, Fujiwara, K, Gonzalez-Martin, A, Harter, P, Kim, J, Ledermann, J, Pujade-Lauraine, E, Quinn, M, Ochiai, K, Zeimet, A, Marth, C, du Bois, A, Hilpert, F, Pfisterer, J, Reuss, A, Friedlander, M, Wilson, M, Kridelka, F, Vergote, I, Berek, J, Dorigo, O, Karam, A, Bekkers, R, Westermann, A, Gatsonis, C, Ng, C, Herraez, A, Ottevanger, N, Poveda, A, Redondo, A, Coleman, R, Lu, K, Gallardo-Rincon, D, Gomez-Garcia, E, Joly, F, Leary, A, Ray-Coquard, I, Burger, R, Moore, K, Fujiwara, H, Hasegawa, K, Gleeson, N, Levy, T, Rosengarten, O, Katsumata, N, Silverberg, S, Sugiyama, T, Chang, S, Kim, B, Nam, B, Colombo, N, Ferrero, A, Lorusso, D, Scambia, G, Edmondson, R, Mcneish, I, Kohn, E, Hirte, H, Mcgee, J, Provencher, D, Sehouli, J, Wimberger, P, Maenpaa, J, Mirza, M, Oza, A, Welch, S, Gaffney, D, Small, W, Glasspool, R, Gourley, C, Millan, D, Zang, R, Zhu, J, Bookman M. A., Okamoto A., Stuart G., Yanaihara N., Aoki D., Bacon M., Fujiwara K., Gonzalez-Martin A., Harter P., Kim J. W., Ledermann J., Pujade-Lauraine E., Quinn M., Ochiai K., Zeimet A., Marth C., du Bois A., Hilpert F., Pfisterer J., Reuss A., Friedlander M., Wilson M. K., Kridelka F., Vergote I., Berek J., Dorigo O., Karam A., Bekkers R., Westermann A., Gatsonis C., Ng C., Herraez A. C., Ottevanger N., Poveda A., Redondo A., Coleman R., Lu K., Gallardo-Rincon D., Gomez-Garcia E., Joly F., Leary A., Ray-Coquard I., Burger R., Moore K. N., Fujiwara H., Hasegawa K., Gleeson N., Levy T., Rosengarten O., Katsumata N., Silverberg S. G., Sugiyama T., Chang S. -J., Kim B. -G., Nam B. -H., Colombo N., Ferrero A., Lorusso D., Scambia G., Edmondson R., McNeish I., Kohn E., Hirte H., McGee J., Provencher D., Sehouli J., Wimberger P., Maenpaa J., Mirza M. R., Oza A., Welch S., Gaffney D., Small W., Glasspool R., Gourley C., Millan D., Zang R., Zhu J., Bookman, M, Okamoto, A, Stuart, G, Yanaihara, N, Aoki, D, Bacon, M, Fujiwara, K, Gonzalez-Martin, A, Harter, P, Kim, J, Ledermann, J, Pujade-Lauraine, E, Quinn, M, Ochiai, K, Zeimet, A, Marth, C, du Bois, A, Hilpert, F, Pfisterer, J, Reuss, A, Friedlander, M, Wilson, M, Kridelka, F, Vergote, I, Berek, J, Dorigo, O, Karam, A, Bekkers, R, Westermann, A, Gatsonis, C, Ng, C, Herraez, A, Ottevanger, N, Poveda, A, Redondo, A, Coleman, R, Lu, K, Gallardo-Rincon, D, Gomez-Garcia, E, Joly, F, Leary, A, Ray-Coquard, I, Burger, R, Moore, K, Fujiwara, H, Hasegawa, K, Gleeson, N, Levy, T, Rosengarten, O, Katsumata, N, Silverberg, S, Sugiyama, T, Chang, S, Kim, B, Nam, B, Colombo, N, Ferrero, A, Lorusso, D, Scambia, G, Edmondson, R, Mcneish, I, Kohn, E, Hirte, H, Mcgee, J, Provencher, D, Sehouli, J, Wimberger, P, Maenpaa, J, Mirza, M, Oza, A, Welch, S, Gaffney, D, Small, W, Glasspool, R, Gourley, C, Millan, D, Zang, R, Zhu, J, Bookman M. A., Okamoto A., Stuart G., Yanaihara N., Aoki D., Bacon M., Fujiwara K., Gonzalez-Martin A., Harter P., Kim J. W., Ledermann J., Pujade-Lauraine E., Quinn M., Ochiai K., Zeimet A., Marth C., du Bois A., Hilpert F., Pfisterer J., Reuss A., Friedlander M., Wilson M. K., Kridelka F., Vergote I., Berek J., Dorigo O., Karam A., Bekkers R., Westermann A., Gatsonis C., Ng C., Herraez A. C., Ottevanger N., Poveda A., Redondo A., Coleman R., Lu K., Gallardo-Rincon D., Gomez-Garcia E., Joly F., Leary A., Ray-Coquard I., Burger R., Moore K. N., Fujiwara H., Hasegawa K., Gleeson N., Levy T., Rosengarten O., Katsumata N., Silverberg S. G., Sugiyama T., Chang S. -J., Kim B. -G., Nam B. -H., Colombo N., Ferrero A., Lorusso D., Scambia G., Edmondson R., McNeish I., Kohn E., Hirte H., McGee J., Provencher D., Sehouli J., Wimberger P., Maenpaa J., Mirza M. R., Oza A., Welch S., Gaffney D., Small W., Glasspool R., Gourley C., Millan D., Zang R., and Zhu J.

Abstract

The Gynecologic Cancer InterGroup (GCIG) Fifth Ovarian Cancer Consensus Conference (OCCC) was held in Tokyo, Japan from 7 to 9 November 2015. It provided international consensus on 15 important questions in 4 topic areas, which were generated in accordance with the mission statement to establish 'International Consensus for Designing Better Clinical Trials'. The methodology for obtaining consensus was previously established and followed during the Fifth OCCC. All 29 clinical trial groups of GCIG participated in program development and deliberations. Draft consensus statements were discussed in topic groups as well as in a plenary forum. The final statements were then presented to all 29 member groups for voting and documentation of the level of consensus. Full consensus was obtained for 11 of the 15 statements with 28/29 groups agreeing to 3 statements, and 27/29 groups agreeing to 1 statement. The high acceptance rate of the statements among trial groups reflects the fact that we share common questions, and recognise important unmet needs that will guide future research in ovarian cancer.

Published
2017

23. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

Author

Ray-Coquard, I, Pautier, P, Pignata, S, Perol, D, Gonzalez-Martin, A, Berger, R, Fujiwara, K, Vergote, I, Colombo, N, Maenpaa, J, Selle, F, Sehouli, J, Lorusso, D, Alia, Emg, Reinthaller, A, Nagao, S, Lefeuvre-Plesse, C, Canzler, U, Scambia, Giovanni, Lortholary, A, Marme, F, Combe, P, de Gregorio, N, Rodrigues, M, Buderath, P, Dubot, C, Burges, A, You, B, Pujade-Lauraine, E, Harter, P, Scambia, G (ORCID:0000-0003-2758-1063), Ray-Coquard, I, Pautier, P, Pignata, S, Perol, D, Gonzalez-Martin, A, Berger, R, Fujiwara, K, Vergote, I, Colombo, N, Maenpaa, J, Selle, F, Sehouli, J, Lorusso, D, Alia, Emg, Reinthaller, A, Nagao, S, Lefeuvre-Plesse, C, Canzler, U, Scambia, Giovanni, Lortholary, A, Marme, F, Combe, P, de Gregorio, N, Rodrigues, M, Buderath, P, Dubot, C, Burges, A, You, B, Pujade-Lauraine, E, Harter, P, and Scambia, G (ORCID:0000-0003-2758-1063)

Abstract

BACKGROUNDOlaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown.METHODSWe conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death.RESULTSOf the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab.CONCLUSIONSIn patients with advanced ovarian cancer receiving first-line stand

Published
2019

24. Harmonising clinical trials within the Gynecologic Cancer InterGroup: consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference

Author

Bookman, M. A., Okamoto, A., Stuart, G., Yanaihara, N., Aoki, D., Bacon, M., Fujiwara, K., González-Martín, A., Harter, P., Kim, J. W., Ledermann, J., Pujade-Lauraine, E., Quinn, M., Ochiai, K., Zeimet, A., Marth, C., du Bois, A., Hilpert, F., Pfisterer, J., Reuss, A., Friedlander, M., Wilson, M. K., Kridelka, F., Vergote, I., Berek, J., Dorig, Karam, A., Bekkers, R., Westermann, A., Gatsonis, C., Ng, C., Herráez, A. C., Ottevanger, N., Poveda, A., Redondo, A., Coleman, R., Lu, K., Gallardo-Rincón, D., Gomez-Garcia, E., Joly, F., Leary, A., Ray-Coquard, I., Burger, R., Moore, K. N., Fujiwara, H., Hasegawa, K., Gleeson, N., Levy, T., Rosengarten, O., Katsumata, N., Silverberg, S. G., Sugiyama, T., Chang, S. -J., Kim, B. -G., Nam, B. -H., Colombo, N., Ferrero, A, Lorusso, D., Scambia, G., Edmondson, R., Mcneish, I., Kohn, E., Hirte, H., Mcgee, J., Provencher, D., Sehouli, J., Wimberger, P., Maenpaa, J., Mirza, M. R., Oza, A., Welch, S., Gaffney, D., Small, W., Glasspool, R., Gourley, C., Millan, D., Zang, R., Zhu, J., Bookman, M, Okamoto, A, Stuart, G, Yanaihara, N, Aoki, D, Bacon, M, Fujiwara, K, Gonzalez-Martin, A, Harter, P, Kim, J, Ledermann, J, Pujade-Lauraine, E, Quinn, M, Ochiai, K, Zeimet, A, Marth, C, du Bois, A, Hilpert, F, Pfisterer, J, Reuss, A, Friedlander, M, Wilson, M, Kridelka, F, Vergote, I, Berek, J, Dorigo, O, Karam, A, Bekkers, R, Westermann, A, Gatsonis, C, Ng, C, Herraez, A, Ottevanger, N, Poveda, A, Redondo, A, Coleman, R, Lu, K, Gallardo-Rincon, D, Gomez-Garcia, E, Joly, F, Leary, A, Ray-Coquard, I, Burger, R, Moore, K, Fujiwara, H, Hasegawa, K, Gleeson, N, Levy, T, Rosengarten, O, Katsumata, N, Silverberg, S, Sugiyama, T, Chang, S, Kim, B, Nam, B, Colombo, N, Ferrero, A, Lorusso, D, Scambia, G, Edmondson, R, Mcneish, I, Kohn, E, Hirte, H, Mcgee, J, Provencher, D, Sehouli, J, Wimberger, P, Maenpaa, J, Mirza, M, Oza, A, Welch, S, Gaffney, D, Small, W, Glasspool, R, Gourley, C, Millan, D, Zang, R, and Zhu, J

Subjects
0301 basic medicine, medicine.medical_specialty, media_common.quotation_subject, Unmet needs, 03 medical and health sciences, 0302 clinical medicine, Documentation, Ovarian cancer, Voting, medicine, Humans, Mission statement, media_common, Randomized Controlled Trials as Topic, Ovarian Neoplasms, business.industry, Consensus conference, Hematology, medicine.disease, Clinical trial, Symposium Articles, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Family medicine, Consensus statement, Needs assessment, Female, business, Needs Assessment
Abstract

The Gynecologic Cancer InterGroup (GCIG) Fifth Ovarian Cancer Consensus Conference (OCCC) was held in Tokyo, Japan from 7 to 9 November 2015. It provided international consensus on 15 important questions in 4 topic areas, which were generated in accordance with the mission statement to establish ‘International Consensus for Designing Better Clinical Trials’. The methodology for obtaining consensus was previously established and followed during the Fifth OCCC. All 29 clinical trial groups of GCIG participated in program development and deliberations. Draft consensus statements were discussed in topic groups as well as in a plenary forum. The final statements were then presented to all 29 member groups for voting and documentation of the level of consensus. Full consensus was obtained for 11 of the 15 statements with 28/29 groups agreeing to 3 statements, and 27/29 groups agreeing to 1 statement. The high acceptance rate of the statements among trial groups reflects the fact that we share common questions, and recognise important unmet needs that will guide future research in ovarian cancer.

Published
2017

25. Associations of serum lipids with metabolic control and diet in young subjects with insulin-dependent diabetes mellitus in Finland

Author

Virtanen, S.M., Rasanen, L., Virtanen, M., Sippola, H., Rilva, A., Kaprio, E.A., Maenpaa, J., and Akerblom, H.K.

Subjects
Type 1 diabetes -- Physiological aspects, Blood lipids -- Physiological aspects, Diabetics -- Physiological aspects, Finland -- Health aspects
Abstract

The associations of serum lipids with metabolic control and diet composition of Finnish adolescents and young adults with insulin-dependent diabetes mellitus were studied. Using glycosylated hemoglobin as an index of metabolic control, results show that diabetics with better metabolic control had lower total cholesterol and serum triglyceride values and a higher high density lipoprotein cholesterol:total cholesterol ratio as compared to diabetics with poor metabolic control.

Published
1993

29. ESMO-ESGO-ESTRO consensus conference on endometrial cancer: Diagnosis, treatment and follow-up

Author

Colombo, N, Creutzberg, C, Amant, F, Bosse, T, Gonzalez-Marton, A, Ledermann, J, Marth, C, Nout, R, Querleu, D, Mirza, M, Sessa, C, Abal, M, Altundag, O, Banerjee, S, Casado, A, De Agustin, L, Cibula, D, Del Campo, J, Emons, G, Goffin, F, Gonzalez-Martin, A, Greggi, S, Haie-Meder, C, Katsaros, D, Kesic, V, Kurzeder, C, Lax, S, Lecuru, F, Levy, T, Lorusso, D, Maenpaa, J, Matias-Guiu, X, Morice, P, Nijman, H, Powell, M, Reed, N, Rodolakis, A, Salvesen, H, Sehouli, J, Taylor, A, Westermann, A, Zeimet, A, Colombo N., Creutzberg C., Amant F., Bosse T., Gonzalez-Marton A., Ledermann J., Marth C., Nout R., Querleu D., Mirza M. R., Sessa C., Abal M., Altundag O., Banerjee S., Casado A., De Agustin L. C., Cibula D., Del Campo J. -M., Emons G., Goffin F., Gonzalez-Martin A., Greggi S., Haie-Meder C., Katsaros D., Kesic V., Kurzeder C., Lax S., Lecuru F., Levy T., Lorusso D., Maenpaa J., Matias-Guiu X., Morice P., Nijman H. W., Powell M., Reed N., Rodolakis A., Salvesen H., Sehouli J., Taylor A., Westermann A., Zeimet A. G., Colombo, N, Creutzberg, C, Amant, F, Bosse, T, Gonzalez-Marton, A, Ledermann, J, Marth, C, Nout, R, Querleu, D, Mirza, M, Sessa, C, Abal, M, Altundag, O, Banerjee, S, Casado, A, De Agustin, L, Cibula, D, Del Campo, J, Emons, G, Goffin, F, Gonzalez-Martin, A, Greggi, S, Haie-Meder, C, Katsaros, D, Kesic, V, Kurzeder, C, Lax, S, Lecuru, F, Levy, T, Lorusso, D, Maenpaa, J, Matias-Guiu, X, Morice, P, Nijman, H, Powell, M, Reed, N, Rodolakis, A, Salvesen, H, Sehouli, J, Taylor, A, Westermann, A, Zeimet, A, Colombo N., Creutzberg C., Amant F., Bosse T., Gonzalez-Marton A., Ledermann J., Marth C., Nout R., Querleu D., Mirza M. R., Sessa C., Abal M., Altundag O., Banerjee S., Casado A., De Agustin L. C., Cibula D., Del Campo J. -M., Emons G., Goffin F., Gonzalez-Martin A., Greggi S., Haie-Meder C., Katsaros D., Kesic V., Kurzeder C., Lax S., Lecuru F., Levy T., Lorusso D., Maenpaa J., Matias-Guiu X., Morice P., Nijman H. W., Powell M., Reed N., Rodolakis A., Salvesen H., Sehouli J., Taylor A., Westermann A., and Zeimet A. G.

Abstract

The first joint European Society for Medical Oncology (ESMO), European SocieTy for Radiotherapy & Oncology (ESTRO) and European Society of Gynaecological Oncology (ESGO) consensus conference on endometrial cancer was held on 11-13 December 2014 in Milan, Italy, and comprised a multidisciplinary panel of 40 leading experts in the management of endometrial cancer. Before the conference, the expert panel prepared three clinically relevant questions about endometrial cancer relating to the following four areas: prevention and screening, surgery, adjuvant treatment and advanced and recurrent disease. All relevant scientific literature, as identified by the experts, was reviewed in advance. During the consensus conference, the panel developed recommendations for each specific question and a consensus was reached. Results of this consensus conference, together with a summary of evidence supporting each recommendation, are detailed in this article. All participants have approved this final article.

Published
2016

31. 5th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: Recurrent Disease

Author

Wilson, MK, Pujade-Lauraine, E, Aoki, D, Mirza, MR, Lorusso, D, Oza, AM, du Bois, A, Vergote, Ignace, Reuss, A, Bacon, M, Friedlander, M, Rincon, D, Joly, F, Chang, S-J, Ferrero, AM, Edmondson, RJ, Wimberger, P, Maenpaa, J, Gaffney, D, Zhang, R, Okamoto, A, Stuart, G, and Ochiai, K

Abstract

This manuscript reports the consensus statements regarding recurrent ovarian cancer (ROC), reached at the 5th Ovarian Cancer Consensus Conference (OCCC), which was held in Tokyo, Japan, in November 2015. Three important questions were identified: (1) What are the subgroups for clinical trials in ROC? The historical definition of using platinum-free interval (PFI) to categorize patients as having platinum-sensitive/resistant disease was replaced by therapy-free interval (TFI). TFI can be broken down into TFIp (platinum-free interval), TFInp (non-platinum-free interval) and TFIb (biological agent-free interval). Additional criteria to consider include histology, BRCA mutation status, number/type of previous therapies, outcome of prior surgery and patient reported symptoms. (2) What are the control arms for clinical trials in ROC? When platinum is considered the best option, the control arm should be a platinum-based therapy with or without an anti-angiogenic agent or a poly (ADP-ribose) polymerase (PARP) inhibitor. If platinum is not considered the best option, the control arm could include a non-platinum drug, either as single agent or in combination. (3) What are the endpoints for clinical trials in ROC? Overall survival (OS) is the preferred endpoint for patient cohorts with an expected median OS less than or equal to 12 months. Progression-free survival (PFS) is an alternative, and it is the preferred endpoint when the expected median OS is more than 12 months. However, PFS alone should not be the only endpoint and must be supported by additional endpoints including predefined patient reported outcomes (PROs), time to second subsequent therapy (TSST), or time until definitive deterioration of quality of life (TUDD). ispartof: Annals of Oncology vol:28 issue:4 pages:727-732 ispartof: location:England status: published

Published
2017

32. Gynecologic Cancer InterGroup (GCIG) consensus review for ovarian sex cord stromal tumors

Author

Ray Coquard, I, Brown, J, Harter, P, Provencher, D, Fong, P, Maenpaa, J, Ledermann, J, Emons, G, Rigaud, D, Glasspool, R, Mezzanzanica, D, Colombo, N, COLOMBO, NICOLETTA, Ray Coquard, I, Brown, J, Harter, P, Provencher, D, Fong, P, Maenpaa, J, Ledermann, J, Emons, G, Rigaud, D, Glasspool, R, Mezzanzanica, D, Colombo, N, and COLOMBO, NICOLETTA

Abstract

Sex cord stromal tumors (SCST) are rare cancers of the ovarian area in adults. They constitute a heterogeneous group of tumors that develop from the sex cords and the ovarian stroma. These tumors are detected typically at an early stage, and they may recur as late as 30 years after the initial treatment. Because 70% of the patients present with stage I tumors, surgery represents the most important therapeutic arm. There are no data to support any kind of postoperative adjuvant treatment for patients with stage IA or IB SCSTs, given the indolent nature of these neoplasms and the overall good prognosis. The long natural history of the disease may lead to repeated surgical procedure should a relapse occurs. Platinum-based chemotherapy is currently used for patients with advanced stage SCSTs or recurrent disease, with an overall response rate of 63% to 80%. The indolent nature of SCSTs with the tendency for late recurrence requires long-term follow-up

Published
2014

33. Neutropenia management and granulocyte colony-stimulating factor use in patients with solid tumours receiving myelotoxic chemotherapy-findings from clinical practice

Author

Krzemieniecki, K, Sevelda, P, Erdkamp, F, Smakal, M, Schwenkglenks, Matthias, Puertas, J, Trojan, A, Szabo, Z, Bendall, K, Maenpaa, J, Krzemieniecki, K, Sevelda, P, Erdkamp, F, Smakal, M, Schwenkglenks, Matthias, Puertas, J, Trojan, A, Szabo, Z, Bendall, K, and Maenpaa, J

Abstract

PURPOSE: Clinical practice adherence to current guidelines that recommend primary prophylaxis (PP) with granulocyte colony-stimulating factors (G-CSFs) for patients at high (≥20 %) overall risk of febrile neutropenia (FN) was evaluated. METHODS: Adult patients with breast cancer, non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or ovarian cancer were enrolled if myelotoxic chemotherapy was planned, and they had an investigator-assessed overall FN risk ≥20 %. The primary outcome was FN incidence. RESULTS: In total, 1,347 patients were analysed (breast cancer, n = 829; NSCLC, n = 224; SCLC, n = 137; ovarian cancer, n = 157). Patients with breast cancer exhibited fewer individual FN risk factors than patients with other cancers and were far more likely to have received a high-FN-risk chemotherapy regimen. However, a substantial proportion of all patients (45-80 % across tumour types) did not receive G-CSF PP in alignment with investigator risk assessment and guideline recommendations. FN occurred in 127 patients overall (9 %, 95% confidence interval (CI) 8-11 %), and incidence was higher in SCLC (15 %) than other tumour types (8 % in ovarian and NSCLC, 9 % in breast cancer). A post hoc analysis of G-CSF use indicated that G-CSF prophylaxis was not given within the recommended timeframe after chemotherapy (within 1-3 days) or was not continued across all cycles in 39 % of patients. CONCLUSIONS: FN risk assessment was predominantly based on clinical judgement and individual risk factors, and guidelines regarding G-CSF PP for patients at high FN risk were not consistently followed. Improved education of physicians may enable more fully informed neutropenia management in patients with solid tumours.

Published
2014

37. Carboplatin–paclitaxel-induced leukopenia and neuropathy predict progression-free survival in recurrent ovarian cancer

Author

Lee, C K, primary, Gurney, H, additional, Brown, C, additional, Sorio, R, additional, Donadello, N, additional, Tulunay, G, additional, Meier, W, additional, Bacon, M, additional, Maenpaa, J, additional, Petru, E, additional, Reed, N, additional, Gebski, V, additional, Pujade-Lauraine, E, additional, Lord, S, additional, Simes, R J, additional, and Friedlander, M, additional

Published
2011
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