The patients in the following trials are not exactly same as current P3 - A7 trial
1. To compare, in 305 patients with advanced metastatic melanoma between temozolomide and (DTIC)
Results - In the intent-to-treat population, median survival time was 7.7 months for patients treated with
temozolomide and 6.4 months for those treated with DTIC.
2. The results of another multicenter phase III trial that randomized 859 patients to receive dacarbazine vs an extended dosing schedule of temozolomide were recently reported - The investigators found no significant differences between dacarbazine and temozolomide in ORR (10% and 14%, respectively), progression-free survival (PFS, 2.1 and 2.3 months, respectively), or OS (9.3 and 9.1 months, respectively).
3. A pooled analysis of 23 randomized, controlled trials showed that the objective response rate (ORR) for 1,390 patients receiving dacarbazine alone was 15.3%. The majority of these responses were partial (11.2% partial responses [PR], 4.2 % complete responses [CR]). Responses are seldom durable, and fewer than 2% of patients treated with dacarbazine alone are alive at 6 years.
Another trial -
At the time of the first interim analysis 55 patients had been enrolled into the DTIC and 53 into the DC-arm (ITT). OR was low (DTIC: 5.5%, DC: 3.8%), - Stage 4 patients
MedImmune, Inc. (Nasdaq: MEDI) today announced that preliminary data from a Phase 2 study involving 112 patients with stage IV metastatic melanoma showed a 12.7-month median survival for patients treated with Vitaxin alone. The data also showed a 9.4-month median survival for patients treated with Vitaxin plus dacarbazine (DTIC). In a recent Phase 3 trial, patients treated with DTIC alone, the current standard of care in advanced melanoma, had a median survival of 7.9 months.
Another one - The investigation included 529 patients with stage IV disease, a performance status of 0 to 1, and no brain metastasis. The researchers assigned 264 patients to receive nab-paclitaxel 150 mg/m2 IV on days 1, 8 and 15 every 4 weeks. The other 265 patients received dacarbazine 1,000 mg/m2 once every 3 weeks.
Patient characteristics — including age (media, 63 years; range, 21 to 87 years),
At the time of planned interim analysis, nab-paclitaxel also was associated with longer OS (12.8 months vs. 10.7 months; HR=0.831; 99.9% CI, 0.578-0.1.196).