| Abstract | BACKGROUND AND PURPOSE: Following our phase II experience, a randomised trial was undertaken to evaluate the efficacy of adding chemotherapy to radiotherapy in patients with unresectable squamous cell cancer of the esophagus. PATIENTS AND METHODS: Patients randomised to the RT group received 50 Gy/25 fx/5 weeks of teletherapy followed 1-2 weeks later with 12 Gy/2 fx of high-dose-rate intra-lumenal brachytherapy spaced a week apart. Following the first 3 years of recruitment, due to unexpected late morbidity, brachytherapy was excluded and the protocol modified to 66 Gy/33 fx/6.5 weeks. The CRT group received identical radiotherapy with concurrent weekly cisplatin at 35 mg/m(2) for 6-7 cycles. RESULTS: Between April 1999 and December 2005, 125 patients were randomised to a RT (n=60) or CRT group (n=65). Radiotherapy treatment was completed in 78% (47/60) of the RT group and 89% (58/65) of the CRT group (P=0.10). Six or more cycles of cisplatin could be delivered in 63% (41/65), which resulted in RTOG grade 3 neutropenia of 3%. Late morbidity in the form of ulcers (5% vs. 15% odds ratio 0.29, 95% CI 0.08-1.11, P=0.08) and strictures (13% vs. 28%, odds ratio 0.40, 95% CI 0.16-1.01, P=0.05) was observed in the RT and CRT groups, respectively. At a median follow up of 23 months of all patients alive (range 6-82 months) and with 95/125 events, the median, 1, 2 and 5 year projected survival was 7.1 months, 32.3%, 22.8% and 13.7% vs. 13.4 months, 57.6%, 38.9% and 24.8% for the RT and CRT groups, respectively (hazard ratio 0.65, 95% CI 0.44-0.98, P=0.038). CONCLUSIONS: The addition of concurrent cisplatin to radiotherapy resulted in a modest improvement in survival and was associated with manageable additional acute and late morbidity. |
| Authors | Shaleen Kumar, Kislay Dimri, Rohini Khurana, Neeraj Rastogi, Koilpillai Joseph Maria Das, Punita Lal
(Affiliation: Department of Radiotherapy, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. shaleenkr at yahoo.com)
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| Journal | Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
(Radiother Oncol)
Vol. 83
Issue 2
Pg. 139-47
(May 2007)
ISSN: 0167-8140 Ireland |
| PMID | 17445928
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
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| Chemical References |
- Antineoplastic Agents
- Cisplatin
|
| Topics |
- Adult
- Aged
- Analysis of Variance
- Antineoplastic Agents
(therapeutic use)
- Brachytherapy
(methods)
- Carcinoma, Squamous Cell
(drug therapy, radiotherapy)
- Chi-Square Distribution
- Cisplatin
(therapeutic use)
- Combined Modality Therapy
- Esophageal Neoplasms
(drug therapy, radiotherapy)
- Female
- Humans
- Male
- Middle Aged
- Proportional Hazards Models
- Radiotherapy Dosage
- Survival Analysis
- Treatment Outcome
|
