Neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation for locally advanced cervical cancer

Abstract

Background Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). Forty percent of patients present with disease recurrence. This study aims to investigate the feasibility, safety and efficacy of neoadjuvant chemotherapy (NACT) with weekly cisplatin and paclitaxel (TP) followed by CCRT. Methods We are conducting a phase III trial comparing the efficacy and side effects of patients with cervical cancer (FIGO 2018 stage IIB to IVA) who were assigned to four cycles of NACT with cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly followed by CCRT or CCRT alone. In this report, we studied the medium-term effect of 50 patients enrolled in the NACT + CCRT arm. The primary endpoints were the response rate post-NACT and 12 weeks post-CCRT evaluated by MR/CT based on RECIST v 1.1. The secondary endpoints were 3-year OS (overall survival) and PFS (progression-free survival) measured by the Kaplan–Meier method. Results Among 50 patients enrolled in the NACT + CCRT arm, the complete and partial response rates were 10.4% and 68.8%, post-NACT. Twelve weeks after treatment completion, the complete response rate was 72.0%, whereas the total response rate (complete and partial response) was 90.0%. After a median follow-up of 28 months, the 3-year OS rate was 83.9%, and the 3-year PFS rate was 73.6%. NACT response was related to superior PFS and OS compared with NACT nonresponse (P < 0.01). Late AEs were exiguous, while early AEs mainly included myelosuppression and gastrointestinal AEs. Conclusions This study showed a good response rate achieved by dose-dense weekly cisplatin and paclitaxel followed by standard CCRT. The treatment regimen is feasible, as evidenced by the acceptable toxicity of NACT and by the high compliance with radiotherapy. Trial registration Protocol version number and date. Chinese clinical trial registry, ChiCTR1900025327; http://www.chictr.org.cn. Registered 24 August 2019. Retrospectively registered, medresman.org.cn/ChiCTR1900025326. The date recruitment began 01–01-2019.

Evolving standards and future directions for systemic therapies in cervical cancer

“…Despite a greater incidence of hematological adverse events (AEs), predominantly neutropenia (19% vs. 5%), which one would expect from additional doublet chemotherapy, completion rates of the induction and CCRT phases were high, and RT delivery was not compromised in the experimental arm. INTERLACE is the first and largest randomized study in LACC to demonstrate an OS advantage from induction chemotherapy before CCRT in the intention-to-treat population, regardless of response to induction chemotherapy [ 14 15 16 ].…”

Survival of Women with Advanced Stage Cervical Cancer: Neo-Adjuvant Chemotherapy Followed by Radiotherapy and Hyperthermia versus Chemoradiotherapy

“…The review by de Azevedo et al reported one phase 2 trial of 22 patients with PELNM and/or PAOLNM with a median DFS and OS at 22 months of 68% and 81%, respectively [30]. Li et al conducted a phase III trial comparing the efficacy and side effects of patients with FIGO 2018 stage IIB to IVA cervical cancer who were assigned to four cycles of NACT with cisplatin (40 mg/m 2 ) and paclitaxel (60 mg/m 2 ) weekly followed by CCRT or CCRT alone [31]. In a preliminary analysis of 50 patients, they reported after a median follow-up of 28 months, a 3-year OS rate of 84%, and a 3-year PFS rate of 74%.…”

Comparison of the clinical efficacy of paclitaxel + carboplatin and paclitaxel + cisplatin on tumor markers and WHOQOL-BREF score on cervical cancer patients

“…At present, neoadjuvant chemotherapy regimens are recommended for patients with intermediate to advanced cervical cancer, as comparatively, the outcomes obtained by surgery alone are considered lower than multimodal treatment approaches [13]. The goals of neoadjuvant chemotherapy treatment for cervical cancer patients encompass four main objectives: complete eradication of subclinical lesions to reduce recurrence rates, effective reduction of tumor size to facilitate comprehensive lesion removal during subsequent surgery, reduction of cancer cell activity, and minimization of the risk of intraoperative or postoperative lesion metastasis [14].…”