In terms of the clinical benefit rate, defined as the overall objective response

In terms of the clinical benefit rate, defined as the overall objective response rate and stable disease rate, there was a trend in favour of the combination arm with 67% in the CG arm compared to 56% in the C arm , but the difference was not statistically significant. Stable disease was observed in 13 patients in the CG arm and in 18 patients in the C arm . 3.4. Survival Seliciclib Roscovitine In september 2007 the median follow-up was 38.3 and 40.3 months in the CG arm and the C arm, respectively. The median OS duration was 11 months and 8 months , in the CG arm and in the C arm, respectively. The 1-year survival rate was 46% in the combination arm and 35% in the C arm. Median PFS was 5 months and 3 months in the CG arm and in the C arm, respectively. The PFS rate at 1 year reached 29% and 15% in the CG arm and the C inhibitor chemical structure arm, respectively. Overall, a non-significantly better outcome was observed for patients treated with CG compared to C, considering OS and PFS . 3.5. Toxicity No toxic deaths occurred. Regarding haematologic toxicities, both neutropenia and thrombocytopenia were more frequently observed in the combination arm compared to the monotherapy arm. The incidence of grade 3?4 neutropenia was 63% versus 12%, respectively. Three cases of febrile neutropenia were reported in the CG arm , not statistically significant compared to the C arm .
The incidence of grade 3?4 thrombocytopenia was 37% versus 4%. Considering blood transfusion, 22% of the patients in the GC arm required erythrocyte transfusion compared to 8% in the C arm. Fifteen percent of the patients in the CG arm required buy Vicriviroc platelet transfusions, whereas none was needed in the C arm.
A summary of adverse events is reported in Table 2. 3.6. Quality of life In the study design, quality of life was considered as a secondary endpoint, but this analysis was not performed due to insufficient patient accrual and the low rate of answers for the second evaluation, after two cycles: only 13 out of the 27 patients in the CG arm and 10 out of 25 in the C arm. 4. Discussion There is currently no established standard chemotherapy regimen for the treatment of patients with CUP which do not fall into the recognised specific entities. Only a few randomised trials have attempted to establish such a regimen.13 One of the main limitations in conducting trials in patients with CUP is the heterogeneity of this cancer patient population. Major progress has been achieved through the identification and validation of simple prognostic factors that can be used either to select or to stratify patients for randomised trials. 5 The present randomised study attempted to test whether a cisplatin?gemcitabine doublet could improve the outcome of patients with a non-unfavourable prognosis according to the GEFCAPI prognostic system versus single agent cisplatin. Unfortunately, as previously reported in other studies by other groups, the trial was closed early before completing its planned enrolment due to poor accrual.13,14

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