Efficacy in high burden locally advanced cervical cancer with concurrent gemcitabine and cisplatin chemoradiotherapy plus adjuvant gemcitabine and cisplatin: prognostic and predictive factors and the impact of disease stage on outcomes from a prospective randomized phase III trial.
OBJECTIVE
We recently published results of a phase III trial demonstrating superior outcomes in patients with locally advanced cervical cancer (LACC) when concurrent cisplatin chemoradiotherapy is supplemented with concurrent gemcitabine and adjuvant gemcitabine/cisplatin. We present prognostic and predictive factors identified in that study, along with analyses of the effect of disease stage and post-study therapy.


METHODS
In that trial, 515 patients with stage IIB-IVA LACC were administered concurrent cisplatin chemoradiotherapy with or without gemcitabine and adjuvant gemcitabine/cisplatin. Cox models were used to identify prognostic and predictive factors. Survival was estimated using the Kaplan-Meier method.


RESULTS
Advanced (stage III-IVA) disease, squamous histology, low hemoglobin, the presence of ≥1 enlarged para-aortic lymph nodes, and large tumor size, were associated with poorer prognosis, regardless of treatment assigned. Tumor size and histology were predictive of treatment efficacy. Chemoradiotherapy supplemented with gemcitabine produced relatively greater benefit in patients with stage III/IVA disease. Post-study therapy did not appear to affect the overall survival outcome.


CONCLUSIONS
Prognostic factors identified in this study are consistent with other reports. The finding of relatively greater benefit in advanced-stage patients makes for an important factor in consideration of treatment for these patients and the design of future studies.
National Cancer Institute/Institute of Biomedical Research, Universidad Nacional Autonoma de Mexico, Av. San Fernando No. 22, Tlalpan 14080, Mexico City, Mexico. alfonso_duenasg@yahoo.com
A
A
Dueňas-González
M
M
Orlando
Y
Y
Zhou
M
M
Quinlivan
H
H
Barraclough
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001918:Brachytherapy; D002294:Carcinoma, Squamous Cell / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008198:Lymph Nodes / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D047368:Tumor Burden; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000628:therapy*; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine