Zie ook literatuurlijst voeding en voedingssuppletie specifiek bij blaaskanker van arts-bioloog drs. Engelbert Valstar:

Zie ook in gerelateerde artikelen

23 oktober 2023: Bron: ESMO 2023, N Engl J Med 2023

De CheckMate 901-studie laat zien bij patiënten met gevorderde blaaskanker dat immuuntherapie met nivolumab (een anti-PD medicijn) en gemcitabine + cisplatine de mediane overall overleving verbeterde met 3 maanden: 21,7 maanden vergeleken met 18,9 maanden voor alleen chemotherapie. De combinatie van nivolumab en chemotherapie leidt ook tot een aanzienlijke verbetering dat de tumor onder controle blijft en niet groeit met ook meer complete remissies, in vergelijking met alleen chemotherapie.

De algehele objectieve respons was 57,6% (complete remissie, 21,7%) met de nivolumab-combinatietherapie en 43,1% (complete remissie, 11,8%) met alleen gemcitabine + cisplatine.

Interessant is ook dat wanneer er een complete remissie is dat die veel langer aanhoudt dan een complete remissie bereikt via chemotherapie. De mediane duur van de complete respons was namelijk 37,1 maanden bij de combinatietherapie met nivolumab en 13,2 maanden bij alleen gemcitabine + cisplatine.

Bijwerkingen van graad 3 of hoger traden op bij respectievelijk 61,8% en 51,7% van de patiënten.

Volgens Michiel van der Heijden Medisch Oncoloog in het Anthonie van Leeuwenhoek ziekenhuis en een van de onderzoekers van deze studie is de kans op overlijden afgenomen met 22% als patiënten werden behandeld met beide medicijnen in vergelijking met patiënten die alleen chemotherapie kregen.
Nu klinkt 22 procent natuurlijk heel veel beter dan drie maanden levensverlenging op nog geen twee jaar, maar goed het AvL is er zo enthousiast over dat ze dit een doorbraak noemen in het behandelen van gevorderde blaaskanker.

Zie dit artikel op de website van het AvL:

Doorbraak in behandeling blaaskanker

Lees ook dit artikel dat de resultaten weergeeft zoals gepresenteerd op ESMO 2023 met grafieken enz:

ESMO 2023: CheckMate 901: Nivolumab plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone for Previously Untreated Unresectable or Metastatic Urothelial Carcinoma: Phase 3 Results

Het volledige studierapport is tegen betaling in te zien:

Nivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma

Michiel S. van der Heijden, M.D., Ph.D.,
Guru Sonpavde, M.D.,
Thomas Powles, M.D.,
Andrea Necchi, M.D.,
Mauricio Burotto, M.D.,
Michael Schenker, M.D., Ph.D.,
Juan Pablo Sade, M.D.,
Aristotelis Bamias, M.D., Ph.D.,
Philippe Beuzeboc, M.D.,
Jens Bedke, M.D.,
Jan Oldenburg, M.D., Ph.D.,
Gurkamal Chatta, M.D.,
for the CheckMate 901 Trial Investigators*

Abstract

BACKGROUND

No new agent has improved overall survival in patients with unresectable or metastatic urothelial carcinoma when added to first-line cisplatin-based chemotherapy.

METHODS

In this phase 3, multinational, open-label trial, we randomly assigned patients with previously untreated unresectable or metastatic urothelial carcinoma either to receive intravenous nivolumab (at a dose of 360 mg) plus gemcitabine–cisplatin (nivolumab combination) every 3 weeks for up to six cycles, followed by nivolumab (at a dose of 480 mg) every 4 weeks for a maximum of 2 years, or to receive gemcitabine–cisplatin alone every 3 weeks for up to six cycles. The primary outcomes were overall and progression-free survival. The objective response and safety were exploratory outcomes.

RESULTS

A total of 608 patients underwent randomization (304 to each group). At a median follow-up of 33.6 months, overall survival was longer with nivolumab-combination therapy than with gemcitabine–cisplatin alone (hazard ratio for death, 0.78; 95% confidence interval , 0.63 to 0.96; P=0.02); the median survival was 21.7 months (95% CI, 18.6 to 26.4) as compared with 18.9 months (95% CI, 14.7 to 22.4), respectively. Progression-free survival was also longer with nivolumab-combination therapy than with gemcitabine–cisplatin alone (hazard ratio for progression or death, 0.72; 95% CI, 0.59 to 0.88; P=0.001). The median progression-free survival was 7.9 months and 7.6 months, respectively. At 12 months, progression-free survival was 34.2% and 21.8%, respectively. The overall objective response was 57.6% (complete response, 21.7%) with nivolumab-combination therapy and 43.1% (complete response, 11.8%) with gemcitabine–cisplatin alone. The median duration of complete response was 37.1 months with nivolumab-combination therapy and 13.2 months with gemcitabine–cisplatin alone. Grade 3 or higher adverse events occurred in 61.8% and 51.7% of the patients, respectively.

CONCLUSIONS

Combination therapy with nivolumab plus gemcitabine–cisplatin resulted in significantly better outcomes in patients with previously untreated advanced urothelial carcinoma than gemcitabine–cisplatin alone. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 901 ClinicalTrials.gov number, NCT03036098. opens in new tab.)

Supported by Bristol Myers Squibb in collaboration with Ono Pharmaceutical.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Drs. van der Heijden and Sonpavde contributed equally to this article.

This article was published on October 22, 2023, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank the patients and their families for making this trial possible; the investigators and the clinical trial teams at Bristol Myers Squibb and Ono Pharmaceutical for trial support; Chandrika Jeyamohan, M.S.N., for contributions to the data analysis and interpretation; Melissa Gibb, R.N., who served as the global trial manager; Steven Blum, M.B.A., M.A., of Bristol Myers Squibb, and Ling Shi, Ph.D., of Evidera, for support with analysis of patient-reported outcomes; the staff of Dako, an Agilent Technologies company, for collaborative development of the PD-L1 IHC 28-8 pharmDx assay; and Nicolette Belletier, Ph.D., of Parexel, who provided medical writing assistance with an earlier version of the manuscript.

Author Affiliations

From the Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam (M.S.H.); Medical Oncology, Genitourinary Section, Dana–Farber Cancer Institute, Harvard Medical School, Boston (G.S.); the Department of Genitourinary Oncology, Barts Cancer Institute, Queen Mary University of London, London (T.P.); the Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); the Department of Oncology, Bradford Hill Clinical Research Center, Santiago, Chile (M.B.); the Department of Medical Oncology, Sf. Nectarie Oncology Center, Department of Oncology, University of Medicine and Pharmacy, Craiova, Romania (M.S.); the Department of Clinical Oncology, Alexander Fleming Institute, Buenos Aires (J.P.S.); the Second Propedeutic Department of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital, Athens (A.B.); the Department of Urologic Oncology, Hopital Foch, Suresnes, France (P.B.); the Department of Urology, Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); the Department of Oncology, Akershus University Hospital, Lørenskog, Norway (J.O.); Roswell Park Comprehensive Cancer Center, Buffalo (G.C.), and the Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York (M.D.G.) — both in New York; the Department of Medical Oncology, Ankara University, Ankara, Turkey (Y.Ü.); the Department of Oncology, Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and the Department of Urology, Peking University First Hospital, Beijing (Z.H.) — both in China; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain (B.P.V.); Seoul National University Hospital, Seoul, South Korea (J.H.K.); the Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan (Y.T.); Bristol Myers Squibb, Princeton, NJ (J.F., L.W., M.Y.P., F.N.); and Bristol Myers Squibb, Boudry, Switzerland (D.P.).

Dr. van der Heijden can be contacted at ms.vd.heijden@nki.nl or at the Department of Medical Oncology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.

A complete list of the investigators in the CheckMate 901 trial is provided in the Supplementary Appendix, available at NEJM.org.

nivolumab, blaaskanker, nivolumab, immuuntherapie, gemcitabine, cisplatin, overall overleving, checkmate 901 studie