Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix.

Abstract

PURPOSE:

To test the hypothesis that cisplatin (CDDP) administered concurrently with standard radiotherapy (RT) would improve pelvic control and survival in patients with advanced squamous cell cancer of the cervix.

PATIENTS AND METHODS:

A total of 259 patients with International Federation of Gynecology and Obstetrics stage IB to IVA squamous cell cervical cancer with central disease greater-than-or-equal 5 cm or histologically confirmed pelvic lymph node involvement were randomized to receive RT (external-beam RT plus brachytherapy) plus weekly CDDP chemotherapy (40 mg/m(2)) (arm 1) or the same RT without chemotherapy (arm 2).

RESULTS:

A total of 253 patients were available for analysis. Median follow-up was 82 months. No significant difference was found in progression-free survival (P =.33). No significant difference in 3- and 5-year survival rates was found (69% v 66% and 62% v 58%, respectively; P =.42). The hazard ratio for survival (arm 2 to arm 1) was 1.10 (95% confidence interval, 0.75 to 1.62).

CONCLUSION:

This study did not show a benefit to either pelvic control or survival by adding concurrent weekly CDDP chemotherapy in a dose of 40 mg/m(2) to radical RT as given in this trial. Careful attention to RT details is important for achieving optimum outcome for patients with this disease.

• Authors: R Pearcey, M Brundage, P Drouin, J Jeffrey, D Johnston, H Lukka, G MacLean, L Souhami, G Stuart, D Tu
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 20 Issue 4 Pg. 966-72 (Feb 15 2002) ISSN: 0732-183X [Print] United States
• PMID: 11844818 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Cisplatin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, pharmacology)
• Brachytherapy
• Carcinoma, Squamous Cell (drug therapy, pathology, radiotherapy)
• Cisplatin (administration & dosage, pharmacology)
• Combined Modality Therapy
• Disease-Free Survival
• Female
• Humans
• Middle Aged
• Treatment Outcome
• Uterine Cervical Neoplasms (drug therapy, pathology, radiotherapy)