van Hagen P. N Engl J Med. 2012;366:2074-2084.
Preoperative chemoradiotherapy doubled median OS among patients with esophageal or esophagogastric junction cancer compared with surgery alone, according to results of a phase 3 trial.
Pieter van Hagen, MD, MCCM, of the department of surgery at the Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues conducted the study to determine whether a chemoradiotherapy regimen — weekly administration of carboplatin and paclitaxel for 5 weeks, concurrently with radiotherapy (41.4 Gy in 23 fractions, 5 days a week) — followed by surgery provided additional benefit when compared with surgery alone.
The researchers enrolled 366 patients with resectable tumors from March 2004 to December 2008. Of those, 275 (75%) had adenocarcinoma, 84 (23%) had squamous cell carcinoma and seven (2%) had large cell undifferentiated
Tumor length could not exceed 8 cm and tumor width could not exceed 5 cm. Only patients with tumors staged at T1N1 or T2-3N0-1 without evidence of metastases were enrolled. No participants had history of other cancer, and none had undergone prior chemotherapy or radiotherapy.
The researchers randomly assigned 178 patients to the chemoradiotherapy arm and 188 patients to surgery alone. Follow-up was 5 years.
Preoperative chemoradiotherapy reduced patients’ risk for death during follow-up by 34%, the researchers said.
Median OS was significantly longer among patients assigned to chemoradiotherapy vs. those assigned to surgery alone (49.4 months vs. 24 months; HR=0.657; 95% CI, 0.495-0.871), according to study results.
Complete resection with no tumor within 1 mm of the resection margins was achieved in 92% of patients in the chemoradiotherapy group vs. 69% of patients assigned to surgery alone (P<.001). A pathological complete response was achieved in 47 of 161 patients (29%) who underwent resection after chemoradiotherapy, according to study results.
Preoperative chemoradiotherapy was associated with acceptable rates of adverse events and could be given as an outpatient treatment, according to researchers.
The most common major hematologic toxic effects reported among patients in the chemoradiotherapy arm were leukopenia (6%) and neutropenia (2%). The most common nonhematologic toxic effects were anorexia (5%) and fatigue (3%).
“Preoperative chemoradiotherapy [is safe and] improved survival among patients with potentially curable esophageal or esophagogastric junction cancer,” van Hagen and colleagues concluded.
- The research was funded by the Dutch Cancer Foundation.