Main Session
Sep 28
QP 14 - Modernizing Definitive Therapy in Cervical Cancer: From Systemic Intensification to Adaptive Radiation

1078 - Bone Marrow-Sparing Extended-Field Chemoradiation with Dose-Dense Neoadjuvant Chemotherapy for FIGO 2018 Stage IIIC2 Cervical Cancer: Early Outcomes of a Prospective Phase II Study

05:05pm - 05:10pm ET
Room 204

Presenter(s)

Surendra Saini, MD, PhD, DPH, FESTRO Headshot
Surendra Saini, MD, PhD, DPH, FESTRO - All India Institute of Medical Sciences, New Delhi, Delhi

S. K. Saini1, N. Das2, S. Sushant3, D. N. Sharma3, K. Kamboj3, A. Shankar4, S. Khurana3, R. Pramanik5, S. Singhal6, B. Kataria7, S. A. Shamim3, and A. Singhal8; 1AIl India Institute of Medical Sciences, New Delhi, Delhi, India, 2All India Institue of Medical Sciences, New Delhi, Delhi, India, 3All India Institute of Medical Sciences, New Delhi, India, 4All India Institute of Medical Sciences, New Delhi, New Delhi, India, 5DM Medical Oncology, AIIMS New Delhi, Delhi, India, 6All Indisa Institute of Medical Sciences, New Delhi, India, 7All India Institute of Medical Sciences, Delhi, India, 8National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India

Purpose/Objective(s):

We hypothesized that dose-dense neoadjuvant chemotherapy followed by PET-guided bone marrow–sparing extended-field chemoradiation would improve 2-year disease-free survival (DFS) by enhancing treatment tolerance and enabling the delivery of intensified systemic and locoregional therapy in stage IIIC2 cervical cancer. The primary objective was to evaluate the 2-year DFS with this combined-modality approach.

Materials/Methods:

This prospective phase II study enrolled patients with ¹8F-FDG PET/CT–staged FIGO IIIC2 cervical carcinoma, adequate organ function, and ECOG performance status 0–2. Treatment comprised six weekly cycles of dose-dense neoadjuvant paclitaxel (60 mg/m²) and carboplatin (AUC 2), followed by extended-field image-guided IMRT with concurrent weekly platinum chemotherapy and brachytherapy. The elective planning target volume received 45 Gy, with simultaneous integrated boosts of 57.5 Gy to para-aortic and 55 Gy to pelvic nodal disease. Pelvic and para-aortic active bone marrow were delineated on co-registered PET/CT using mean standardized uptake value thresholds and prioritized during planning. High-dose-rate brachytherapy was delivered as 7 Gy in four fractions to achieve cumulative HR-CTV D90 =85 Gy EQD2. Survival outcomes were estimated using the Kaplan–Meier method with a prespecified 24-month landmark analysis.

Results:

Twenty-five patients were enrolled, and all completed the protocol-specified neoadjuvant chemotherapy, definitive extended-field chemoradiotherapy, and brachytherapy as planned. The median age was 50 years (range, 34–68 years). Patients received a median of six cycles of neoadjuvant chemotherapy and three cycles of concurrent chemotherapy. Protocol-defined PET-guided pelvic and para-aortic bone marrow–sparing planning objectives were achieved in most patients. At three months post-treatment, complete metabolic response on ¹8F-FDG PET/CT was observed in 24 patients (96%), with partial metabolic response in one patient (4%). With a median follow-up of 28 months, three recurrent events were observed, resulting in an estimated 2-year disease-free survival (DFS) of 88%. One death occurred, corresponding to an estimated 2-year overall survival probability of 96%. The median overall survival was not reached.

Conclusion:

In this prospective phase II analysis of FIGO IIIC2 cervical cancer, dose-dense neoadjuvant chemotherapy followed by PET-guided bone marrow–sparing extended-field IG-IMRT with concurrent chemotherapy and image-guided brachytherapy was associated with high metabolic response rates and favorable 2-year disease-free and overall survival probabilities. When compared with contemporary extended-field chemoradiation series that did not incorporate neoadjuvant chemotherapy or functional bone marrow–sparing techniques, these outcomes are encouraging and support further evaluation of this integrated treatment strategy in randomized studies.