Zie ook literatuurlijst niet-toxische medicijnen en behandelingen specifiek bij blaaskanker van arts-bioloog drs. Engelbert Valstar.

12 mei 2021: Bron: Journalo of Clinical Oncology

Sacituzumab govitecan , een medicijn dat voor uitgezaaide borstkanker stadium 4 officieel is goedgekeurd, geeft bij patiënten met lokaal gevorderde inoperabele of uitgezaaide urineleiderkanker - blaaskanker met progressie van hun ziekte na eerdere op platina gebaseerde chemo en immuuntherapie met anti-PD medicijnen alsnog uitstekende resultaten met zelfs enkele complete remissies erbij. 

Het totale responspercentage was 27,4%, inclusief 5,3% complete remissies en 22,1% gedeeltelijke remissies. Bij 33,6% van de patiënten werd stabiele ziekte waargenomen. De mediane responsduur was 7,2 maanden en de mediane totale overleving was 10,9 maanden. De therapie werd goed verdragen, met als meest voorkomende behandelingsgerelateerde bijwerkingen van graad 3 neutropenie, leukopenie, bloedarmoede - anemie, diarree en febriele neutropenie.

(Sacituzumab govitecan is een antilichaam-geneesmiddelconjugaat dat bestaat uit een antilichaam dat zich richt op het menselijke Trophoblast cell surface antigen 2 (Trop-2), dat tot expressie komt in de meeste borstkankers, gekoppeld aan SN-38 (een topoisomerase I-remmer))

De onderzoekers stellen voor om bij deze groep van zwaarvoorbehandelde blaaskankerpatiënten Sacituzumab govitecan toe te voegen aan een behandelingsprotocol. 

Het volledige studierapport is gratis in te zien. Klik op de titel van het abstract:

ORIGINAL REPORTS

Genitourinary Cancer

TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors

Scott T. Tagawa , MD, MS1; Arjun V. Balar, MD2; Daniel P. Petrylak , MD3; Arash Rezazadeh Kalebasty , MD4; Yohann Loriot, MD, PhD5; Aude Fléchon, MD, PhD6; ...Show More
Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/


ABSTRACT

PURPOSE

Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2–directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC.

METHODS

TROPHY-U-01 (ClinicalTrials.gov identifier: NCT03547973) is a multicohort, open-label, phase II, registrational study. Cohort 1 includes patients with locally advanced or unresectable or mUC who had progressed after prior PLT and CPI. Patients received SG 10 mg/kg on days 1 and 8 of 21-day cycles. The primary outcome was centrally reviewed ORR; secondary outcomes were progression-free survival, OS, duration of response, and safety.

RESULTS

Cohort 1 included 113 patients (78% men; median age, 66 years; 66.4% visceral metastases; median of three [range, 1-8] prior therapies). At a median follow-up of 9.1 months, the ORR was 27% (31 of 113; 95% CI, 19.5 to 36.6); 77% had decrease in measurable disease. Median duration of response was 7.2 months (95% CI, 4.7 to 8.6 months), with median progression-free survival and OS of 5.4 months (95% CI, 3.5 to 7.2 months) and 10.9 months (95% CI, 9.0 to 13.8 months), respectively. Key grade ≥ 3 treatment-related adverse events included neutropenia (35%), leukopenia (18%), anemia (14%), diarrhea (10%), and febrile neutropenia (10%), with 6% discontinuing treatment because of treatment-related adverse events.

CONCLUSION

SG is an active drug with a manageable safety profile with most common toxicities of neutropenia and diarrhea. SG has notable efficacy compared with historical controls in pretreated mUC that has progressed on both prior PLT regimens and CPI. The results from this study supported accelerated approval of SG in this population.


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sacituzumab govitecan, blaaskanker, urineleiderkanker, fase III studie, overall overleving, complete remissie, immuuntherapie


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