Severe acute and late toxicities
The grade ≥3 acute toxicity profile of CCRT is listed in Table 3. Acute toxicity reactions were assessed in all 82 patients. The most common hematologic toxicity was leukopenia, with 15 (18.3%) patients and ten (12.2%) patients having grade 3 and 4 leukopenia, respectively. Most patients recovered by using G-CSF. Grade ≥3 thrombocytopenia was reported in three (3.6%) patients and six (7.3%) patients experienced grade ≥3 anemia. Twenty-eight patients got esophagitis during the treatment, including five (6.1%) patients and two (2.4%) patients with grade 3 and 4 esophagitis, respectively. Other main grade ≥3 nonhematologic toxicities included dysphagia (6.1%), nausea/vomiting (3.7%), mucositis (2.4%), and diarrhea (4.9%). One patient died of a fistula 0.97 months after the completion of treatment, and no cardiac toxicities or hypersensitivity reactions and alopecia related to PTX were reported. In terms of late toxicity, 12 (14.6%) patients got esophageal stenosis and six (7.3%) patients experienced radiation-related pneumonitis. Severe late radiation-associated toxicities affecting skin and heart were rare. In general, the regimen was well tolerated.
Survival and prognostic analysis
As shown in Figure 2, the median follow-up and OS of the overall population were 20.4 months (range, 0.97–67.4 months) and 26.9 months (95% CI, 23.2–30.6), respectively. The 2-year OS rate for stage I–II and III–IV was 76.0% and 38.6%, respectively. The median PFS of the overall population was 18.2 months (95% CI, 11.583–24.817), and the 2-year PFS rate for stage I–II and III–IV was 64.0% and 21.2%, respectively. Univariate analyses were performed to assess the predictive capability of each variable (Table 4). The results suggested that several covariates were significantly associated with the OS: T stage (P=0.001), N stage (P=0.000), M stage (P=0.021), clinical stage (P=0.000), Charlson comorbidity score (P=0.002), dysphagia (P=0.013), clinical response (P=0.001), ECOG PS (P=0.032), and albumin (P=0.001). The variables significantly associated with the PFS were T stage (P=0.000), N stage (P=0.000), clinical stage (P=0.000), Charlson comorbidity score (P=0.015), dysphagia (P=0.006), clinical response (P=0.000), and albumin (P=0.003).
(To view a larger version of Figure 2, click here.)
(To view a larger version of Table 4, click here.)
To identify independent prognostic factors, the factors that were found to be significant on univariate analysis were subjected to multivariate analysis. Multivariate analysis revealed that clinical stage (P-value was 0.042 and 0.024, respectively) was the independent factor affecting OS and PFS in elderly patients, and CR rate (P=0.054) had statistical significance with PFS (Table 5).