Purkayastha Abhishek, Sharma Neelam, Sundaram Viswanath, Jaiswal Pradeep, Husain Azhar
Department of Radiation Oncology, Command Hospital (Southern Command), Pune, Maharashtra, India.
Department of Radiation Oncology, Army Hospital (Research and Referral), New Delhi, India.
J Cancer Res Ther. 2023 Apr-Jun;19(3):675-683. doi: 10.4103/jcrt.jcrt_940_21.
This single institutional study compared neoadjuvant concurrent chemo-radiotherapy (NACCRT) and neoadjuvant chemotherapy (NACT) followed by surgery in locally advanced middle and lower-1/3 carcinoma esophagus patients in terms of toxicity, clinical response, operative complications, disease downstaging, resection rates, pathological response, recurrence, and survival.
This randomized prospective comparative study comprised 40 consecutive patients divided equally between two study arms NACCRT (n = 20; 41.4 Gy radiation dose; carboplatin area under the curve (AUC) 2/paclitaxel 50 mg/m; 5 cycles) and NACT (n = 20; carboplatin AUC 5/paclitaxel 175 mg/m; 2 cycles) from March 2014 to December 2016. Follow-up was done for 4 years. Chi-square test, Fischer's-exact test were used for comparative analysis and Kaplan-Meier analysis for survival.
Statistically significant esophagitis in NACCRT and peripheral-neuropathy in NACT was observed (P < 0.001). NACCRT recorded more postoperative complications, higher complete resection (R0) rates, and pathologically complete response (pCR). Tumor downstaging was significant in both study groups (n < 0.001). Four-year median disease-free survival (DFS) and overall survival (OS) were 28.50 months and 38 months in NACCRT versus 28 months and 35.5 months in NACT, respectively. In both NACCRT and NACT, pCR cases showed improved median DFS and OS compared to pathological partial response (pPR) (n < 0.001).
This study demonstrated significant activity and tolerable toxicity of taxane-based therapy in NACCRT and NACT. Both groups recorded no survival benefit over each other, although pCR cases resulted in statistically significant survival advantage compared to clinical partial response. NACCRT resulted in lesser toxicity, numerically higher R0-resection, pCRs, median DFS, and OS compared to NACT.
本单机构研究比较了新辅助同步放化疗（NACCRT）和新辅助化疗（NACT）后手术治疗局部晚期中下段食管癌患者在毒性、临床反应、手术并发症、疾病降期、切除率、病理反应、复发和生存方面的差异。
本随机前瞻性对照研究纳入了40例连续患者，于2014年3月至2016年12月平均分为两个研究组，NACCRT组（n = 20；放疗剂量41.4 Gy；卡铂曲线下面积（AUC）2/紫杉醇50 mg/m；5个周期）和NACT组（n = 20；卡铂AUC 5/紫杉醇175 mg/m；2个周期）。随访4年。采用卡方检验、费舍尔精确检验进行比较分析，采用Kaplan-Meier分析进行生存分析。
观察到NACCRT组有统计学意义的食管炎和NACT组有周围神经病变（P < 0.001）。NACCRT组术后并发症更多，完全切除（R0）率更高，病理完全缓解（pCR）率更高。两个研究组的肿瘤降期均显著（n < 0.001）。NACCRT组的4年无病生存期（DFS）和总生存期（OS）中位数分别为28.50个月和38个月，而NACT组分别为28个月和35.5个月。在NACCRT组和NACT组中，与病理部分缓解（pPR）相比，pCR病例的DFS中位数和OS均有所改善（n < 0.001）。
本研究表明基于紫杉烷的治疗在NACCRT和NACT中具有显著活性和可耐受的毒性。两组之间均未观察到生存获益，尽管与临床部分缓解相比，pCR病例在统计学上具有显著的生存优势。与NACT相比，NACCRT的毒性较小，R0切除率、pCR率、DFS中位数和OS在数值上更高。
