Multicenter phase II study of chemo-immunotherapy in the treatment of metastatic renal cell carcinoma.
The purpose of this study was to evaluate the potential efficacy of a chemo-immunotherapy regimen for the treatment of metastatic renal cell carcinoma (MRCC). Forty-one patients with progressing MRCC and with a median age of 63 years were recruited. Planned treatment consisted of 6 courses of capecitabine 1000 mg/m twice daily on days 1 to 14 every 4 weeks, pegylated alpha-interferon 2b 50 microg every week, interleukin-2 1.8 M IU subcutaneously, and oral 13-cis-retinoic acid 0.5 mg/kg, all given 5 days/wk, 3 weeks of each month. After 6 courses of concomitant biochemotherapy, biotherapy was continued in patients who had a clinical benefit. The primary end point was response; secondary end points were the evaluation of the immunologic parameters, toxicity, progression-free, and overall survival. The treatment was well-tolerated. Grade 3 and 4 neutropenia and thrombocytopenia occurred in 5% and 7% of patients, respectively. The overall response rate in the 41 evaluable patients was 53.6% (95% confidence interval 37%-69%). Median progression-free and overall survivals were 14.7 and 27.8 months, respectively. A sustained improvement in all evaluated immunologic parameters was observed in the 36 patients treated with maintenance biotherapy. Six cycles of biochemotherapy, being followed by maintenance immunotherapy is well-tolerated and shows significant activity in patients with MRCC.
Recchia
Francesco
F
Ospedale Civile di Avezzano, Unità Operativa di Oncologia, Monterotondo, Roma. frecchia1946@libero.it
Saggio
Gaetano
G
Amiconi
Giovanna
G
Di Blasio
Anna
A
Cesta
Alisia
A
Candeloro
Giampiero
G
Necozione
Stefano
S
Fumagalli
Luca
L
Rea
Silvio
S
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000473:pathology* / Q000628:therapy*; D003131:Combined Modality Therapy / Q000379:methods; D004358:Drug Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D007680:Kidney Neoplasms / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents