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1. [Recent treatment results for metastatic melanoma: data from the Dutch Melanoma Treatment Registry]

Author

Zeijl, M.C.T. van, Eertwegh, A.J. van den, Wouters, M., Jochems, A., Schouwenburg, M.G., Haanen, J., Aarts, M.J., Berkmortel, F. van den, Groot, J.W.B. de, Hospers, G.A., Kapiteijn, E., Koornstra, R.H., Piersma, D., Rijn, R.S. van, Suijkerbuijk, K.P., Tije, A.J. Ten, Veldt, A.A.M. van der, Vreugdenhil, G., and Hoeven, K.J.M. van der

Subjects
Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2], Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Abstract

Item does not contain fulltext OBJECTIVE: To evaluate treatment strategies and survival of patients with unresectable stage IIIc or IV melanoma since the 2012 introduction of new drugs in the Netherlands. DESIGN: Prospective cohort study. METHOD: We analysed data from the Dutch Melanoma Treatment Registry (DMTR) regarding patients diagnosed with unresectable stage IIIc or IV melanoma in the period of 1 July 2012 to 31 December 2015. We estimated survival times using the Kaplan-Meier method. The relationship between year of diagnosis and survival was estimated using Cox regression analysis, adjusted for age, WHO performance status, lactate dehydrogenase values, stage, brain metastases and distant metastases. RESULTS: Out of 2,768 registered patients, approximately three-quarters received systemic therapy. This treatment was subject to change every year. Median survival was 10.7 months (95% CI: 9.6-13.2) in 2012 and 13.8 months (95% CI: 11.8-15.6) in 2015. Median survival for patients receiving systemic therapy was 17.1 months in 2015. 2-year survival in this period increased from 23% to 40%. Patients diagnosed in 2015 had better survival than patients of 2014 (hazard ratio (HR) 0.82; 95% CI: 0.73-0.93). This was also true for patients receiving systemic therapy (HR: 0.79; 95% CI: 0.69-0.91). CONCLUSION: Fast availability of new drugs, initiated by the then minister of VWS (health, welfare and sport) and the professional organisation, has thoroughly changed treatment of unresectable stage IIIc and IV melanoma. Data from the DMTR indicate safe use of these new drugs in daily practice and improved survival of advanced-melanoma patients in recent years.

Published
2018

2. Recente behandelresultaten van uitgezaaid melanoom

Author

van Zeijl, MCT, Van den Eertwegh, AJM, Wouters, MWJM, Jochems, A, Schouwenburg, MG, Haanen, JBAG, Aarts, MJ, van den Berkmortel, FWPJ, de Groot, JWB, Hospers, GAP, Kapiteijn, E, Koornstra, RH, Piersma, D, van Rijn, RS, Suijkerbuijk, KPM, ten Tije, AJ, van der Veldt, Astrid, Vreugdenhil, G, van der Hoeven, KJM, and Medical Oncology

Published
2018

5. Recent treatment results for metastatic melanoma: Data from the Dutch Melanoma Treatment Registry,Recente behandelresultaten van uitgezaaid melanoom: Gegevens uit de Dutch Melanoma Treatment Registry

Author

Zeijl, M. C. T., Den Eertwegh, A. J. M., Wouters, M. W. J. M., Jochems, A., Schouwenburg, M. G., Haanen, J. B. A. G., Aarts, M. J., Den Berkmortel, F. W. P. J., Groot, J. W. B., Hospers, G. A. P., Ellen Kapiteijn, Koornstra, R. H., Piersma, D., Rijn, R. S., Suijkerbuijk, K. P. M., Ten Tije, A. J., Veldt, A. A. M., Vreugdenhil, G., and Hoeven, K. J. M.

6. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Author

Thomas Powles, Michiel S van der Heijden, Daniel Castellano, Matthew D Galsky, Yohann Loriot, Daniel P Petrylak, Osamu Ogawa, Se Hoon Park, Jae-Lyun Lee, Ugo De Giorgi, Martin Bögemann, Aristotelis Bamias, Bernhard J Eigl, Howard Gurney, Som D Mukherjee, Yves Fradet, Iwona Skoneczna, Marinos Tsiatas, Andrey Novikov, Cristina Suárez, André P Fay, Ignacio Duran, Andrea Necchi, Sophie Wildsmith, Philip He, Natasha Angra, Ashok K Gupta, Wendy Levin, Joaquim Bellmunt, Michiel S. van der Heijden, Jae Lyun Lee, Bernhard J. Eigl, Som D. Mukherjee, Cristina Suarez, Hans Westgeest, Aude Flechon, Yen-Chuan Ou, Inkeun Park, Vsevolod Matveev, Begoña Pérez-Valderrama, Susanna Cheng, Stephen Frank, Urbano Anido, Alketa Hamzaj, Margitta Retz, Srikala Sridhar, Giorgio Vittorio Scagliotti, Jens Voortman, Boris Alekseev, Anna Alyasova, Boris Komyakov, Herlinde Dumez, Michel Pavic, Go Kimura, Atsushi Mizokami, Susanne Osanto, Jose Angel Arranz, Djura Piersma, Sang Joon Shin, Oleg Karyakin, Ignacio Delgado, Jose Luis Gonzalez, See-Tong Pang, Anna Tran, Oleg Lipatov, Wen-Pin Su, Thomas Flaig, Ajjai Alva, Hwa Park Kyong, Evgeny Kopyltsov, Elena Almagro, Monserrat Domenech, Yen-Hwa Chang, Brieuc Sautois, Andre Ravaux, Gerasimos Aravantinos, Vasileios Georgoulias, Sasja Mulder, Yu Jung Kim, Fabio Kater, Christine Chevreau, Scott Tagawa, Pawel Zalewski, Florence Joly, Gencay Hatiboglu, Luca Gianni, Franco Morelli, Rosa Tambaro, Yasuhiro Hashimoto, Alexander Nosov, Albert Font, Alejo M. Rodriguez-Vida, Robert Jones, Naveen Vasudev, Sandhya Srinivas, Jingsong Zhang, Thierry Gil, Daygen Finch, Marc-Oliver Grimm, Yu-Li Su, Simon Chowdhury, Christopher Hocking, Eugen Plas, Scott North, Niels Viggo Jensen, Christine Theodore, Florian Imkamp, Avivit Peer, Takashi Kobayashi, Hideki Sakai, Naoto Sassa, Kazuhiro Yoshimura, Maureen Aarts, Ana Ferreira Castro, Marlen Topuzov, Juan Francisco Rodriguez, Federico Jose Vazquez, Yu-Chieh Tsai, Simon Crabb, Syed Hussain, Johanna Bendell, Marine Gross-Goupil, Gravis Gwenaelle, Raanan Berger, Galina Statsenko, Linda Evans, Alexandra Drakaki, Bradley Somer, Ian Davis, James Lynam, Giuliano Borges, Aldo Dettino, André P. Fay, Graziella Martins, Luis Eduardo Zucca, Mads Agerbaek, Haralambos Kalofonos, Eli Rosenbaum, Hideki Enokida, Hiroaki Kikukawa, Kazuo Nishimura, Satoshi Tamada, Motohide Uemura, Yamil Lopez, Jourik Gietema, Marcin Slojewski, Isabel Fernandes, Alexey Smolin, Danish Mazhar, Arash Rezazadeh Kalebasty, Bradley Carthon, Wolfgang Loidl, Fabio Franke, Gustavo Girotto, Nimira Alimohamed, Robyn Macfarlane, Helle Pappot, Guenter Niegisch, Dimitrios Mavroudis, Avishay Sella, Camillo Porta, Shin Ebara, Motonobu Nakamura, Wataru Obara, Norihiko Okuno, Nobuo Shinohara, Mikio Sugimoto, Akitaka Suzuki, Noriaki Tokuda, Hiroji Uemura, Akito Yamaguchi, Francisco Ramirez, Pawel Rozanowski, Pawel Wiechno, Bhumsuk Keam, Nikolay Kislov, Denis Plaksin, Irfan Cicin, Satish Kumar, Matthew D. Galsky, Daniel P. Petrylak, Joseph Rosales, Ulka Vaishampayan, Stephane Culine, Christos Papandreou, Taketoshi Nara, Mustafa Erman, Laurence Kreiger, Juliana Janoski, Diogo Rosa, Mariana Siqueira, Christina Canil, Lisa Sengelov, Jean-Marc Tourani, Gaku Arai, Katsuyoshi Hashine, Mutsushi Kawakita, Noboru Nakaigawa, Hayahito Nomi, Hiroaki Shiina, Hiroyoshi Suzuki, Junji Yonese, Roberto Kuri, Eleazar Macedo, Samuel Rivera, Alberto Villalobos Prieto, Anna Polakiewicz-Gilowska, Renata Zaucha, Fabio Lopes, Roman Ponomarev, Mark Pomerantz, Shahrokh Shariat, Cynthia Luk, Krzysztof Lesniewski-Kmak, Graduate School, CCA - Cancer Treatment and quality of life, Internal medicine, Medical oncology, Powles, T., van der Heijden, M. S., Castellano, D., Galsky, M. D., Loriot, Y., Petrylak, D. P., Ogawa, O., Park, S. H., Lee, J. -L., De Giorgi, U., Bogemann, M., Bamias, A., Eigl, B. J., Gurney, H., Mukherjee, S. D., Fradet, Y., Skoneczna, I., Tsiatas, M., Novikov, A., Suarez, C., Fay, A. P., Duran, I., Necchi, A., Wildsmith, S., He, P., Angra, N., Gupta, A. K., Levin, W., Bellmunt, J., Lee, J. L., Westgeest, H., Flechon, A., Ou, Y. -C., Park, I., Matveev, V., Perez-Valderrama, B., Cheng, S., Frank, S., Anido, U., Hamzaj, A., Retz, M., Sridhar, S., Scagliotti, G. V., Voortman, J., Alekseev, B., Alyasova, A., Komyakov, B., Dumez, H., Pavic, M., Kimura, G., Mizokami, A., Osanto, S., Arranz, J. A., Piersma, D., Shin, S. J., Karyakin, O., Delgado, I., Gonzalez, J. L., Pang, S. -T., Tran, A., Lipatov, O., Su, W. -P., Flaig, T., Alva, A., Park Kyong, H., Kopyltsov, E., Almagro, E., Domenech, M., Chang, Y. -H., Sautois, B., Ravaux, A., Aravantinos, G., Georgoulias, V., Mulder, S., Kim, Y. J., Kater, F., Chevreau, C., Tagawa, S., Zalewski, P., Joly, F., Hatiboglu, G., Gianni, L., Morelli, F., Tambaro, R., Hashimoto, Y., Nosov, A., Font, A., Rodriguez-Vida, A. M., Jones, R., Vasudev, N., Srinivas, S., Zhang, J., Gil, T., Finch, D., Grimm, M. -O., Su, Y. -L., Chowdhury, S., Hocking, C., Plas, E., North, S., Jensen, N. V., Theodore, C., Imkamp, F., Peer, A., Kobayashi, T., Sakai, H., Sassa, N., Yoshimura, K., Aarts, M., Ferreira Castro, A., Topuzov, M., Rodriguez, J. F., Vazquez, F. J., Tsai, Y. -C., Crabb, S., Hussain, S., Bendell, J., Gross-Goupil, M., Gwenaelle, G., Berger, R., Statsenko, G., Evans, L., Drakaki, A., Somer, B., Davis, I., Lynam, J., Borges, G., Dettino, A., Martins, G., Zucca, L. E., Agerbaek, M., Kalofonos, H., Rosenbaum, E., Enokida, H., Kikukawa, H., Nishimura, K., Tamada, S., Uemura, M., Lopez, Y., Gietema, J., Slojewski, M., Fernandes, I., Smolin, A., Mazhar, D., Kalebasty, A. R., Carthon, B., Loidl, W., Franke, F., Girotto, G., Alimohamed, N., Macfarlane, R., Pappot, H., Niegisch, G., Mavroudis, D., Sella, A., Porta, C., Ebara, S., Nakamura, M., Obara, W., Okuno, N., Shinohara, N., Sugimoto, M., Suzuki, A., Tokuda, N., Uemura, H., Yamaguchi, A., Ramirez, F., Rozanowski, P., Wiechno, P., Keam, B., Kislov, N., Plaksin, D., Cicin, I., Kumar, S., Rosales, J., Vaishampayan, U., Culine, S., Papandreou, C., Nara, T., Erman, M., Kreiger, L., Janoski, J., Rosa, D., Siqueira, M., Canil, C., Sengelov, L., Tourani, J. -M., Arai, G., Hashine, K., Kawakita, M., Nakaigawa, N., Nomi, H., Shiina, H., Suzuki, H., Yonese, J., Kuri, R., Macedo, E., Rivera, S., Villalobos Prieto, A., Polakiewicz-Gilowska, A., Zaucha, R., Lopes, F., Ponomarev, R., Pomerantz, M., Shariat, S., Luk, C., Lesniewski-Kmak, K., Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Urologic Neoplasms, Durvalumab, Time Factors, medicine.medical_treatment, Population, Neutropenia, Antibodies, Monoclonal, Humanized, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Agents, Immunological, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, education, Immune Checkpoint Inhibitors, Aged, Chemotherapy, education.field_of_study, business.industry, Hazard ratio, Carcinoma, Antibodies, Monoclonal, Middle Aged, medicine.disease, Gemcitabine, Carboplatin, 030104 developmental biology, Treatment Outcome, Oncology, chemistry, 030220 oncology & carcinogenesis, Female, Urothelium, business, Tremelimumab, medicine.drug
Abstract

Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma.Methods: DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice–web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24.Findings: Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9–43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4–17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4–15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71–1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1–18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9–14·0) in the chemotherapy group (0·85, 95% CI 0·72–1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (Interpretation: This study did not meet either of its coprimary endpoints. Further research to identify the patients with previously untreated metastatic urothelial carcinoma who benefit from treatment with immune checkpoint inhibitors, either alone or in combination regimens, is warranted.Funding: AstraZeneca.

Published
2020

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