Chemo: Topotecan gives no added value in phase III study, even shorter time to relapse after operation in patients, administered eierstokkanker stage III and IV versus carboplatin-paclitaxel.

25 February 2005: source: J Clin Oncol. 2004 Jul 1; 22 (13): 2635-42.

Topotecan administered after operation in patients eierstokkanker stage III and IV and investigated in randomized phase III study-273 carboplatin/paclitaxel eierstokkanker patients took part-opposite gives no added value. Time to relapse was even shorter in the topotecangroep than in the carboplatin/paclitacelgroep. Here is the abstract of this study.

Topotecan compared with no therapy after response to carboplatin/paclitaxel in patients with ovarian surgery and cancer: Italian multicenter Trials in Ovarian Cancer (MITO-1) randomized study.

The Placido S, G, Di Vagno G Scambia, Naglieri E, Lombardi AV, M, Carteni G, Biamonte R, Marinaccio Manzione L, A, A, Febbraro, Valerio MR. Matteis Gasparini G, Danese S, F Perrone, Lauria R, De Laurentiis M, S, C, S. Greggi Gallo Pignata Istituto Nazionale Tumori, via M-80131 Napoli, Italy; Semmola, email: sandro.pignata@fondazionepascale.it

PURPOSE: Topotecan is an active second-line treatment for advanced ovarian cancer. Its efficacy as consolidation treatment after first-line standard chemotherapy is unknown.

PATIENTS AND METHODS: To investigate whether topotecan (1.5 mg/m (2) on days 1 through 5, four cycles, every 3 weeks) prolonged progression-free survival (PFS) for patients responding to standard carboplatin and paclitaxel (area under the curve 5) (175 mg/m (2) administered as a 3-hour infusion in six cycles; CP), a multicenter phase III study was performed with an 80% power to detect a 50% prolongation or median PFS. Patients were registered at diagnosis and randomized after the end or CP.

RESULTS: Two hundred seventy-three patients were randomly assigned (topotecan, n = 137; observation, n = 136), with a median age of 56 years. Internship at diagnosis was advanced in three fourths of patients (stage III or stage IV in 65% patients; in 10%); after primary surgery, 46% had no residual disease and 20% were optimally debulked. After CP, 87% reached a clinical complete response, and 13% achieved a partial response. Neutropenia (grade 3/4 in 58% of the patients) and thrombocytopenia (grade 3 in 21%; grade 4 in 3%) were the most frequent toxicities attributed to topotecan. There was no statistically significant difference in PFS between the arms (P =. 83; log-rank test): median PFS was 18.2 months in the topotecan arm and 28.4 in the control arm. Hazard ratio or progression for patients receiving topotecan was 1.18 (95% CI, 0.86 to 1.63) after adjustment for residual disease, interval debulking surgery, and response to CP.

CONCLUSION: The present analysis indicates that consolidation with topotecan does not improve PFS for patients with advanced ovarian cancer chemotherapy with carboplatin and paclitaxel who respond to initial.

PMID: 15226331 [PubMed-indexed for MEDLINE]