Preoperative Radiochemotherapy in Esophageal Squamous Cell Cancer with 5-Fluorouracil/Cisplatin or Carboplatin/Paclitaxel: Treatment Practice over a 20-Year Period and Implications for the Individual Treatment Modalities

We retrospectively studied outcomes in patients treated with preoperative radiochemotherapy and surgery for esophageal squamous cell cancer. We put special focus on the comparison of patients treated with 5-fluorouracil/cisplatin (‘Walsh’) or carboplatin/paclitaxel (‘CROSS’). We compared characteristics between patients treated according to ‘Walsh’ vs. ‘CROSS’. Cox regression was performed to test for an association of parameters with outcomes. Study eligibility was met by 90 patients. First, the higher age and more comorbidities of the ‘CROSS’ patients, along with a shorter intensive care/intermediate care stay, might reflect an improvement in supportive and surgical/perioperative procedures over the periods. Second, the ‘CROSS’ patients experienced more hematologic toxicity and were less likely to complete chemotherapy as per protocol. This indicates that efforts should be taken to guide patients through a toxic treatment regimen by supportive measures. Third, the negative prognostic impact of radiochemotherapy-related toxicities (i.e., dysphagia and hematologic toxicities) and the duration of the intensive care/intermediate care unit stay underlines that further optimization of treatment procedures remains an important goal. We found no differences in tumor downstaging and survival between treatment regimen. Toxicity profiles could be improved by tailoring the regimen to individual patients (e.g., careful use of the taxane-based regimen in elderly patients).

Tailored treatment strategy for locally advanced rectal carcinoma: Five-year results of the French phase II, randomized, multicenter GRECCAR4 trial.

4014 Background: Preoperative radiochemotherapy and total mesorectal excision are the standard-of-care for locally-advanced rectal carcinoma, but some patients are over- or undertreated. Our phase II study assessed the feasibility of tailored radiochemotherapy, based on tumor response to induction high-dose chemotherapy (FOLFIRINOX). Methods: We enrolled 206 patients; good responders after chemotherapy (≥75% tumor volume reduction) were randomly assigned to immediate surgery (arm A) or standard radiochemotherapy (Cap 50: 50 Gy and oral capecitabine daily) plus surgery (arm B). Poor responders were randomly assigned to Cap 50 (arm C) or intensive radiochemotherapy (Cap 60 (60 Gy irradiation), arm D) before surgery. Results: After induction treatment, 194 patients were classified as good (n=30, 15%) or poor (n=164, 85%) responders, and included in arms A and B (16 and 14 patients) or C and D (113 and 51 patients). The primary objective was obtained: (90% CI) R0 resection rates in the four arms respectively were 100% (74–100), 100% (85–100), 83% (72–91), and 88% (77–95). At 5 years: overall survival 90% (CI: 47.3-98.5), 93.3% (CI: 61.3-99.0), 84.3% (CI: 71.0-91.8), 86.1% (CI: 71.6-93.5); disease-free survival 80% (CI: 40.9-94.6), 89.5% (CI: 64.1-97.3), 72.9% (CI: 58.5-82.9), 72.8% (CI: 57.7-83.2); local recurrence 0, 0, 2.1% (CI: 0.3-13.9), 9.3% (CI: 3.6-23.0); metastasis 20% (CI: 5.4-59.1), 10.5% (CI: 2.7-35.9), 18% (CI: 31.8-94.6), 18.8% (CI: 10.2-33.0). Late morbidity and quality of life evaluations showed no significant difference between arms. Conclusions: Tailoring preoperative radiochemotherapy based on induction treatment response is safe and promising. Early tumoral response to induction chemotherapy can discriminate tumor prognosis. Clinical trial information: NCT01333709 .