Safety and activity of sunitinib in elderly patients (≥ 70 years) with metastatic renal cell carcinoma: a multicenter study.
BACKGROUND
Actual tolerability of sunitinib is still poorly documented in elderly patients with metastatic renal cell carcinoma (mRCC).


METHODS
Charts of elderly patients treated with sunitinib for mRCC were reviewed in six Italian centers to assess safety (primary objective), efficacy and correlation of toxicity with comprehensive geriatric assessment (CGA) (secondary objectives).


RESULTS
Sixty-eight patients were eligible, and the median age was 74 years. CGA was carried out in 34 patients (41% fit, 41% vulnerable and 18.5% frail). The dose reduction to 37.5 mg was made upfront or soon after the first cycle in 69.1%. More frequent toxic effects were fatigue (80.9%), mucositis (61.8%) and hypertension (58.8%). Cardiac events occurred in nine patients. In 10 patients, therapy was interrupted early due to rapidly progressive disease (10.3%) or severe toxicity (4.4%: 1 cardiac failure, 1 fatigue, 1 febrile neutropenia). At a median follow-up of 27.1 months, the median OS was 18.3 months and the median PFS was 13.6 months. Correlation was not found between frailty at CGA with severe toxicity nor with response.


CONCLUSIONS
Treatment with sunitinib is effective in elderly patients; yet early interruptions were frequent. Starting treatment at reduced dose and escalating in the absence of severe toxicity could be suggested.
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IOV, IRCCS Padova. Electronic address: antonella.brunello@ioveneto.it.
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Brunello
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IOV, IRCCS Padova.
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Basso
Division of Medical Oncology, Santa Maria della Misericordia Hospital, Udine.
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Sacco
Unit of Medical Oncology, University of Verona, Verona.
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Sava
Unit of Medical Oncology, San Bortolo Hospital, Vicenza.
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De Vivo
Medical Oncology Department, Istituto Toscano Tumori, Viareggio.
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Camerini
Division of Medical Oncology, Civil Hospital of Rovigo, Rovigo.
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Barile
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IOV, IRCCS Padova.
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Roma
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IOV, IRCCS Padova.
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Maruzzo
Unit of Medical Oncology 2, Istituto Oncologico Veneto-IOV, IRCCS, Padova, Italy.
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Falci
Unit of Medical Oncology 1, Istituto Oncologico Veneto-IOV, IRCCS Padova.
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Zagonel
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D000077210:Sunitinib; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib