A Randomized Study of Radiotherapy Alone Versus Radiotherapy Plus 5-Fluorouracil and Platinum in Patients With Inoperable, Locally Advanced Squamous Cancer of the Esophagus

Abstract

Squamous cell cancer of the esophagus is the most common cancer among black South African males, and 60% of patients present with localized inoperable disease. Combined chemoradiotherapy has been reported to be superior to radiotherapy alone for localized inoperable esophageal cancer in North American patients. A study was carried out to determine if this was also applicable to South African patients, who present with more advanced disease. From September 1991 through June 1995, 70 patients with locally advanced (T3N0-1M0) squamous cancer of the esophagus were prospectively randomized to receive radiotherapy alone or radiotherapy combined with cisplatin and 5-fluorouracil. There was no statistically significant survival difference between the two groups. The median survival was 144 days in the group receiving radiotherapy alone, and 170 days in the group receiving radiotherapy combined with chemotherapy (p = 0.42). The degree of weight loss before initiation of therapy had a significant effect on survival regardless of the treatment arm. Radiotherapy in combination with chemotherapy, as administered in this study for South African patients with locally advanced, inoperable squamous cancer of the esophagus, is no better than radiotherapy alone.

Safety and Efficacy of Concurrent Cisplatin and Radiotherapy in Inoperable or Metastatic Squamous Cell Esophageal Cancer

“…The in uence of patient selection on outcome is perhaps best demonstrated in a randomized study from South Africa in which only patients with T3N0-1 stage disease were accrued and were randomized to receive either 2 cycles of CI 5-FU »CDDP and 40 Gy:10 fractions split-course RT or RT alone. The median OS was 5.6 vs. 4.8 months in the CT »RT and RT groups, respectively (non-signi cant) (2). The median OS in our analysis was 9 months with a survival probability of 17% at 4 years, which was reasonable considering the locally advanced and inoperable status of these patients and 14% with distant metastasis at diagnosis.…”

“…This trial also documented severe or life-threatening toxicity in 44% and 20% of cases, respectively, and overall compliance to the stipulated protocol was about 54%. A similar but less dose-intensive regimen in a phase III trial using CDDP and 5-FU could not replicate these results, and furthermore, was associated with signi cantly higher levels of toxicity than those found in the radiotherapy arm (2). The present study is a report on the safety and ef cacy of a moderately intensive chemotherapy schedule of single agent CDDP given concurrently with radiotherapy in inoperable or metastatic esophageal cancers.…”

Definitive and Neoadjuvant Radiochemotherapy of Squamous Cell Carcinoma of the Oesophagus

“…Although two studies [1,2] with 59 and 70 patients, respectively, were too small to achieve statistically significant results, both studies show a trend towards superiority of RCT. The 3 other studies with more patients [3][4][5] show superior results of concurrent RCT in their median survival times as well as in the 2-or 5-year survival rate.…”

Multiple Management Modalities in Esophageal Cancer: Combined Modality Management Approaches

“…The EORTC conducted a trial with 221 patients, randomizing them either to 40 Gy of radiation alone (given as 20 Gy over 5 days × 2, split course with a gap of 2 weeks) or the same radiation regimen given with cisplatin (given for four cycles after radiation and before each XRT course). This study detected a significant difference in progression-free survival (11.3 versus 6.2 months, p = 0.015), longer median survival, and better local control in the group receiving cisplatin; however, overall survival was not affected [26]. Araujo et al randomized 59 patients with stage II esophageal SCC to either radiation alone (50 Gy in 25 fractions) or chemoradiation with 5-FU on days 1-3, mitomycin-C on day 1 of radiation, and weekly bleomycin [15].…”