Abstract
4633 Background: Paclitaxel (T) has shown significant activity both in cisplatin-refractory and untreated GCT patients (pts). In order to determine the impact of T on survival (OS) and toxicity the analysis compares the results of two prospective trials in pts with ‘poor prognosis’ GCT. Methods: In the first trial pts have received high dose VIP chemotherapy (HD-VIP) at dose level [etoposide 250 mg/sqm, ifosfamide 2 g/sqm, cisplatin 20 mg/sqm, d1–5, q d22] for 3 consecutive cycles as part of a phase I/II dose trial. Pts received G-CSF 5 μg/kg s.c. from d+1 after treatment to leukocyte recovery >2000/μl and reinfusion of PBSC at day +2. The comparative trial consisted of pts treated in an identical fashion but additionally receiving T at a dose of 225 mg/sqm added on day 1 as a 3-h infusion prior to cisplatin (HD-VIP+T. Results: 155 pts have been analyzed, 59 pts in HD-VIP and 96 pts in HD-VIP+T. 112 pts and 414 cycles are fully assessable for toxicity, 152 pts for OS. Pts characteristics (HD-VIP compared to HDVIP+T): Median age 29 (16–42) vs. 31 yrs (18–54), mediastinal primary 11 vs. 24%, liver mets 40 vs. 40%, bone 7 vs. 4%, CNS 20 vs. 19%, elevated AFP, HCG, LDH: 39 vs. 30%, 61 vs. 58% and 77 vs. 77%. Dose intensity of the 3- vs. 4-drug regimen achieved have been 98% and 95%. Median time to recovery of granulocytes and thrombocytes (>500/μl resp. >25.000μl) have been day 15 and 16 independent from the addition of T. Differences in grade III/IV toxicity in favor of HD-VIP were seen in terms of stomatitis (14 vs. 49%), neutropenic fever (3 vs. 20%) and manifest infection (3 vs. 19%) (P.05). 88% of pts attained a favorable response (NED/CR/PRm-) to HD-VIP compared to 67% in the HD-VIP+T (P<.05). After a median follow up period of 34 mos (range, 9–78) and 16 (0–47) the calculated 3-yr OS rates were 69.9 (CI95%, 54.3–83.3) for HD-VIP and 67.3% (56.3–78.3) for HD-VIP+T (P=.3). Early death rate due to progression/toxicity was 3% in both trials. Conclusions: The addition of paclitaxel to HD-VIP dose level 6 as first-line therapy was associated with a moderately elevated toxicity. No substantial impact on survival can be anticipated for HD-VIP+T. No significant financial relationships to disclose.
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