Phase II study of sequential treatment of advanced XXXX : three cycles of high-dose @entity1259 plus @entity900 followed by weekly @entity1206 .

@entity1 @entity1665 @entity137 @entity1353 @entity1149 @entity1259 @entity900 @entity1206 @entity1398 @entity158
Previous phase I, II, and III studies on high-dose @entity1259 (HDEPI), alone or in combination with @entity900 (CP), indicate an interesting activity of this drug in the treatment of @entity1149 ( @entity1149 ). However, the toxicological profile of HDEPI limits its prolonged use. In our experience, @entity1206 (VNR) seems to be a suitable drug for long-term monotherapy for advanced @entity1149 . On these grounds, advanced @entity1149 @entity1 were treated with the following strategy: 3 consecutive cycles of CP 60 mg/m2 and HDEPI 120 mg/m2 on day 1, every 3 weeks; then, irrespective of response, weekly VNR at a dose of 25 mg/m2 was administered at home. From December 1996 to March 1998, 25 @entity1 entered the study. After receiving 3 cycles of CP/HDEPI, 8 @entity1 (32%) had a partial response and 3 (12%) had a minor response. Nine @entity1 had stable disease (36%) and 4 (16%) had progressive disease. Twenty-three @entity1 received weekly VNR, and the median number of administrations was 10 (range, 1-38). After VNR treatment, we observed a partial response in 2 @entity1 who previously had stable disease. Therefore, the overall response rate to sequential treatment was 40%; median time to progression was 7 months (range, 2-26 months). The major @entity137 due to the CP/HDEPI regimen were @entity1398 (72%) and @entity1665 (80%). During the VNR treatment, grade 3/4 @entity1398 was seen in 36% of @entity1 . The doses and the timing of VNR administrations were modified according to @entity137 . Symptoms such as cough, @entity1353 , and @entity158 , present in 21 @entity1 before the treatment, improved in 11 cases (52%). Median overall survival is 9 months (range, 3-40+ months); one @entity1 is still alive after 40 months. One- and 2-year survival rates are, respectively, 44% and 16%. This study confirms the activity of CP/HDEPI in @entity1149 and indicates that the sequential treatment of CP/HDEPI for 3 cycles followed by weekly VNR could be considered an effective strategy for locally advanced or metastatic @entity1149 .
