BackgroundCamrelizumab and chemotherapy demonstrated durable antitumor activity with a manageable safety profile as first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC). This study aimed to evaluate the safety and efficacy of camrelizumab plus neoadjuvant chemotherapy, using pathologically complete response (pCR) as primary endpoint, in the treatment for locally advanced ESCC.MethodsPatients with locally advanced but resectable thoracic ESCC, staged as T1b-4a, N2-3 (≥3 stations), and M0 or M1 lymph node metastasis (confined to the supraclavicular lymph nodes) were enrolled. Eligible patients received intravenous camrelizumab (200 mg, day 1) plus nab-paclitaxel (100 mg/m2, day 1, 8, 15) and carboplatin (area under curve of 5 mg/mL/min, day 1) of each 21-days cycle, for two cycles before surgery. The primary endpoint is pCR rate in the per-protocol population. Safety was assessed in the modified intention-to-treat population that was treated with at least one dose of camrelizumab.ResultsFrom November 20, 2019 to December 22, 2020, 60 patients were enrolled. 55 (91.7%) patients completed the full two-cycle treatment successfully. 51 patients underwent surgery and R0 resection was achieved in 50 (98.0%) patients. pCR (ypT0N0) was identified in 20 (39.2%) patients and 5 (9.8%) patients had complete response of the primary tumor but residual disease in lymph nodes alone (ypT0N+). 58 patients (96.7%) had any-grade treatment-related adverse events (TRAEs), with the most common being leukocytopenia (86.7%). 34 patients (56.7%) had adverse events of grade 3 or worse, and one patient (1.7%) occurred a grade 5 adverse event. There was no in-hospital and postoperative 30-day as well as 90-day mortality.ConclusionsThe robust antitumor activity of camrelizumab and chemotherapy was confirmed and demonstrated without unexpected safety signals. Our findings established camrelizumab and chemotherapy as a promising neoadjuvant treatment for locally advanced ESCC.Trial registration numberChiCTR1900026240.
It remains unclear whether non-intubated video-assisted thoracoscopic surgery (VATS) is comparable or advantageous compared with conventional intubated VATS. Thus, we systematically assessed the feasibility and safety of non-intubated VATS compared with intubated VATS perioperatively for the treatment of different thoracic diseases. An extensive search of literature databases was conducted. Perioperative outcomes were compared between 2 types of operations. The time trend of the overall results was evaluated through a cumulative meta-analysis. Subgroup analyses of different thoracic diseases and study types were examined. Twenty-seven studies including 2537 patients were included in the analysis. A total of 1283 patients underwent non-intubated VATS; intubated VATS was performed on the other 1254 patients. Overall, the non-intubated VATS group had fewer postoperative overall complications [odds ratios (OR) 0.505; P < 0.001]; shorter postoperative fasting times [standardized mean difference (SMD) −2.653; P < 0.001]; shorter hospital stays (SMD −0.581; P < 0.001); shorter operative times (SMD −0.174; P = 0.041); shorter anaesthesia times (SMD −0.710; P < 0.001) and a lower mortality rate (OR 0.123; P = 0.020). Non-intubated VATS may be a safe and feasible alternative to intubated VATS and provide a more rapid postoperative rehabilitation time than conventional intubated VATS.
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