Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial

Sunitinib‐induced changes in circulating endothelial cell‐related proteins in patients with metastatic renal cell cancer

“…Overall, the median PFS time was 7.0 months (range, 0.5-47.1 months) and the median OS time was 12.3 months (range, 0.5-41.1 months). In comparison with a previously published compassionate use cohort of sunitinib-treated mRCC patients, 26 the median PFS and OS in this study were relatively short, which can be explained by a higher number of patients in the MSKCC poor risk group as well as a lower number of patients in the favorable risk group.…”

Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients

“…This finding is consistent with the results from both the IDC original and external validation datasets demonstrated that poor-risk patients show a median OS of 8.8 and 7.8 months, respectively (4, 7) and compares favorably to subset analysis of phase III and IV trials (8,9). In the pivotal phase III trial only 6.4% patients with poor-risk MSKCC criteria were included, rendering a median OS of 5.3 months (95% CI: 4.2-10.0 months) with sunitinib compared with 4.0 months (95% CI: 2.7-7.2 months) with IFN-alpha (HR: 0.660; 95% CI: 0.360-1.207) (8).…”

“…Although grade 1 and 2 AE might have been underreported, a high proportion (39.6%) of patients experienced grade 3 or higher AEs. In our series, the rates of grade ≥3 fatigue, nausea, vomiting, and diarrhea are higher than those previously reported in both controlled and non-controlled studies (Table-4) (8)(9)(10)(11)(12). The high proportion of serious AE might be explained by the broader eligibility criteria.…”

“…In the pivotal phase III trial only 6.4% patients with poor-risk MSKCC criteria were included, rendering a median OS of 5.3 months (95% CI: 4.2-10.0 months) with sunitinib compared with 4.0 months (95% CI: 2.7-7.2 months) with IFN-alpha (HR: 0.660; 95% CI: 0.360-1.207) (8). Similarly, the expanded access program (EAP) included 9% poor-risk patients according MSKCC criteria (373 out of 4564 total subjects) and found the same median OS of 5.3 months (95% CI: 4.6-5.4 months) (9). It must be highlighted that the numerical variations in median OS described across these different studies might be, at least in part, due to the fact of different poor risk classification, since 14% of MSKCC intermediate-risk patients are reclassified as poor-risk when stratified by IDC criteria (4).…”

Prise en charge du cancer du rein de stade avancé : Mise à jour 2013 des lignes directrices consensuelles du Forum canadien sur le cancer du rein

“…Parmi les autres options, notons le sunitinib, selon les analyses par sous-groupes de l'essai portant sur l'accès élargi et montrant son innocuité et son efficacité; le sorafénib, selon les analyses par sousgroupes de l'essai ARCCS (Advanced Renal Cell Carcinoma Sorafenib) portant sur l'accès élargi et montrant son innocuité et son efficacité, et le temsirolimus, selon l'analyse par sousgroupes des données des études de phase III [27][28][29][30] . Chez les patients atteints d'un hypernéphrome sarcomatoïde avancé ou métastatique ou d'un hypernéphrome mal différencié, les options incluent le sunitinib, en fonction d'études prospectives et sans randomisation du programme d'accès élargi; le sorafénib, selon l'étude ARCCS prospective et sans randomisation portant sur l'accès élargi; la chimiothérapie, en fonction des études de phase II portant sur des agents comme le 5FU, la gemcitabine, la doxorubicine et des associations de ces agents montrant une efficacité; et le temsirolimus, en fonction de l'analyse par sous-groupes de l'essai pivot de phase III auquel ces patients étaient admissibles [27][28][29]31 .…”