Phase II trial of weekly i.v. @entity1206 as a single agent in first-line advanced XXXX chemotherapy. The Latin-American experience.

@entity1 @entity137 @entity390 @entity0 @entity5 @entity391 @entity1206 @entity1897 @entity3028
This study investigated the therapeutic effect of single-agent i.v. weekly @entity1206 ( @entity1206 ), a semisynthetic vinca alkaloid, in @entity1 who had received no prior treatment for locally advanced or metastatic @entity0 . Of 68 @entity1 entered into the study, 63 were adequate inclusions, assessable for @entity137 and response by WHO criteria; the 5 @entity1 who were not evaluated were excluded from analysis because they were found not to meet the eligibility criteria of the study. @entity1206 was given as a weekly 30 mg/m2 short i.v. (20 minutes) infusion; treatment was continued until disease progression. The overall response rate was 44% (complete response 8%, partial response 36%). The response rate according to target was lymph nodes, 62.9%; liver, 50.0%; lung, 50.0%; skin, 37.5%; and @entity5 , 30.8%. The median duration of response was 17.9 weeks (range: 7-52 weeks). The median time to treatment failure was 12.9 weeks, and the median survival was 50.3 weeks. The 63 eligible @entity1 received 501 cycles. The mean dose intensity was 76%. At least one episode of WHO grade 3/4 @entity3028 was seen in 46% of the @entity1 (13.6% of cycles). Significant @entity390 / @entity391 was seen in only 5% of @entity1 corresponding to 1% of cycles. Only 5% of @entity1 developed WHO grade 3-4 constipation and grade 3 @entity1897 was observed in 1.6% of @entity1 . Alopecia was rare (6.3% of @entity1 ), and other side effects were uncommon. This study confirms that @entity1206 has major single-agent antitumor activity as frontline therapy in advanced @entity0 . Given its excellent tolerance profile and low morbidity, it should be recommended for inclusion in first-line combination chemotherapy regimens.
