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Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial
Yang, Hong; Liu, Hui; Chen, Yuping; Zhu, Chengchu; Fang, Wentao; Yu, Zhentao; Mao, Weimin; Xiang, Jiaqing; Han, Yongtao; Chen, Zhijian; Yang, Haihua; Wang, Jiaming; Pang, Qingsong; Zheng, Xiao; Yang, Huanjun; Li, Tao; Lordick, Florian; D'Journo, Xavier Benoit; Cerfolio, Robert J; Korst, Robert J; Novoa, Nuria M; Swanson, Scott J; Brunelli, Alessandro; Ismail, Mahmoud; Fernando, Hiran C; Zhang, Xu; Li, Qun; Wang, Geng; Chen, Baofu; Mao, Teng; Kong, Min; Guo, Xufeng; Lin, Ting; Liu, Mengzhong; Fu, Jianhua
Purpose The efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC. Patients and Methods From June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m2 intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m2 IV day 1, or 25 mg/m2 IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival. Results The pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S ( P = .212). Conclusion This trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events.
PMID: 30089078
ISSN: 1527-7755
CID: 3226622
Technical and operational modifications required for evolving robotic programs performing anatomic pulmonary resection
Smood, Benjamin; Ghanim, Asem; Wei, Benjamin; Cerfolio, Robert J
The objectives of this study are to review the complicated and often confusing technical changes required when converting from the Si robotic system to the Xi when performing pulmonary lobectomy and segmentectomy. We reviewed a prospective database of a consecutive series of patients who intended to undergo robotic lobectomy or segmentectomy by one surgeon. There were 101 lobectomies and 25 segmentectomies performed on the Si robot in 2015-2016, and 95 lobectomies and 28 segmentectomies in 2016 on the Xi robot. The two groups were similar for age, height, weight, pulmonary function, anatomic resections, and co-morbidities. Technical differences in robotic arm numbering, port placement, and instrumentation are shown below. Median docking time was shorter with the Xi robot [7.5 (95% CI 6-8) versus 10 (95% CI 9-12) min, p = 0.003] as was operation duration [114 (95% CI 104-123) versus 119 (95% CI 116-126) min, p = 0.041] and skin closure to room exit [12 (95% CI 10-24) versus 13 (95% CI 12-15) min, p = 0.081]. Anesthesiologists expressed greater comfort with the Xi system, because the patient's head was not covered by the robot. Outcomes for Si and Xi operations such as median blood loss (20 cc versus 20 cc), transfusion rate (0 versus 0), major complication rate (3.2 versus 3.3%), and the 30- and 90-day mortality were no different (one 30-day death in the Si group). The technical changes that are required for robotic Si-to-Xi conversion are shown. The Xi system may offer improved operational efficiency.
PMID: 29363007
ISSN: 1863-2491
CID: 3181882
Innovation can emerge from a culture of standardization [Editorial]
Cerfolio, Robert J
PMID: 29895382
ISSN: 1097-685x
CID: 3155212
ERAS is 20 years old-now it's time to standardized the intra-op part of our care [Comment]
Cerfolio, Robert J
PMCID:6072933
PMID: 30123538
ISSN: 2072-1439
CID: 3246062
Do we measure what matters to patients and why? [Letter]
Cerfolio, Robert James
PMID: 29776295
ISSN: 1097-685x
CID: 3121582
Are predictive models useful in clinical medicine? [Comment]
Cerfolio, Robert J
PMCID:6036054
PMID: 30023085
ISSN: 2072-1439
CID: 3201892
Lean, Efficient, and Profitable Operating Rooms: How I Teach It [Editorial]
Cerfolio, Robert J
PMID: 29391148
ISSN: 1552-6259
CID: 3010632
Techniques for lung surgery: a review of robotic lobectomy
Chen, Sophia; Geraci, Travis C; Cerfolio, Robert James
INTRODUCTION/BACKGROUND:Robotic lobectomy is an increasingly common surgical approach for anatomic lung resection. Over the last decade, robotic lobectomy has shown to be safe, with oncologic efficacy similar to lobectomy via thoracotomy or video-assisted thoracoscopic surgery (VATS). Comparative analysis between these modalities is an active area of investigation. While initially expensive, the costs of a robotic platform decrease as the number of operations performed increases, length of stay is shortened, and postoperative morbidity is reduced. Moreover, the added cost has value which is defined over long periods of time. Areas covered: The clinical technique and optimal conduct of lobectomy is explained in granular detail for all five types of lobectomies. The advantages and disadvantages of a robotic platform are analyzed, including a review of the recent literature. Expert commentary: The number of robotic pulmonary resections performed has tripled in the past two years. Anticipated developments in robotic surgery include improvements in robotic training, continued refinement of robotic instrumentation, and additional adjunctive technologies. The overall costs of robotic surgery will decrease, in part, due to increasing competition as additional companies enter the market.
PMID: 29504417
ISSN: 1747-6356
CID: 2975082
It is all about the quality of the data [Editorial]
Cerfolio, Robert J
PMID: 29221744
ISSN: 1097-685x
CID: 2962982
Early Oral Feeding Following McKeown Minimally Invasive Esophagectomy: An Open-label, Randomized, Controlled, Noninferiority Trial
Sun, Hai-Bo; Li, Yin; Liu, Xian-Ben; Zhang, Rui-Xiang; Wang, Zong-Fei; Lerut, Toni; Liu, Chia-Chuan; Fiorelli, Alfonso; Chao, Yin-Kai; Molena, Daniela; Cerfolio, Robert J; Ozawa, Soji; Chang, Andrew C
OBJECTIVE: Our objective was to evaluate the impact of early oral feeding (EOF) on postoperative cardiac, respiratory, and gastrointestinal (CRG) complications after McKeown minimally invasive esophagectomy for esophageal cancer. SUMMARY BACKGROUND DATA: Nil-by-mouth with enteral tube feeding is routinely practiced after esophagectomy. METHODS: Patients were randomly allocated to receive oral feeding on the first postoperative day (EOF group) or late oral feeding (LOF group) 7 days after surgery. The primary endpoint was the occurrence of postoperative CRG complications, and the secondary outcomes included bowel function recovery and short-term quality of life (QOL). RESULTS: Between February 2014 and October 2015, 280 patients were enrolled in this study. There were 140 patients in the EOF group and 140 patients in the LOF group. EOF was noninferior to LOF for CRG complications (30.0% in the EOF group vs. 32.9% in the LOF group; 95% confidence interval of the difference: -13.8% to 8.0%). Compared with the LOF group, the EOF group showed significantly shorter time to first flatus (median of 2 days vs. 3 days, P = 0.001) and bowel movement (median of 3 vs. 4 days, P < 0.001). Two weeks after the operation, patients in the EOF group reported higher global QOL and function scores and lower symptom scores than patients in the LOF group. CONCLUSIONS: In patients after McKeown minimally invasive esophagectomy is noninferior to the standard of care with regard to postoperative CRG complications. In addition, patients in the EOF group had a quicker recovery of bowel function and improved short-term QOL.
PMCID:5937132
PMID: 28549015
ISSN: 1528-1140
CID: 2676882