Neoadjuvant and adjuvant chemotherapy of cervical XXXX : mature results of the phase 2 PBM-PFU protocol.

@entity1 @entity137 @entity5 @entity900 @entity1732 @entity1499 @entity420 @entity1487
OBJECTIVE: The mature results of the neoadjuvant and adjuvant chemotherapy arms of the nonrandomized, phase 2 Yale University @entity900 , @entity1732 , @entity1499 , and @entity1487 protocol are presented. METHODS: Sixty-seven @entity1 were prospectively accrued with a median follow-up of 5.4 years, and standard parameters of @entity137 and efficacy were studied. Both univariate and multivariate analyses were applied. RESULTS: The 5-year disease-free survival of 78% for the 25 @entity1 in the adjuvant group, of which 80% had high-risk features including positive margins, parametria, and lymph nodes and 28% had @entity420 , was comparable to recent relevant literature. Only 64% of @entity1 in this group received consolidation radiation therapy, which did not impact on survival. Only 12% of @entity1 recurred distantly. Notably, those who received 4 months or more of chemotherapy had prolonged survival (P = 0.012). In the neoadjuvant group, chemotherapy response rate among 42 @entity1 (with stages 1B-IIIB @entity5 ) was 79% (50% partial response, 29% complete response), and no @entity1 progressed. In the subgroup of 22 @entity1 who underwent surgery after chemotherapy, 59% had nonsquamous histology. Forty-five percent of @entity1 with stage IIB @entity5 were deemed operable after chemotherapy. Ninety-five percent received postoperative radiation therapy. There was a 9% pathologic complete response rate, with positive lymph nodes found in 27%. Notably, those who received 3 months or less of chemotherapy had improved overall survival (P = 0.030). Survival rates of these 22 @entity1 at 3 and 5 years were 73% and 63%, respectively. Although not randomized, these survival rates were similar to those achieved with chemoradiation. CONCLUSIONS: Although there are several logistical/design features of the @entity900 , @entity1732 , @entity1499 , and @entity1487 regimen that are not in line with the current chemotherapy era, our experience with this well-tolerated regimen can serve as a proof of principle. Our data suggests that both neoadjuvant and adjuvant @entity900 -based neoadjuvant chemotherapy may have their place. It also raises the possibility that the optimal duration of chemotherapy in adjuvant cases should be longer than in neoadjuvant cases.
