scholarly journals Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus: the (NEOCRTEC5010) trial—a timely and welcome clinical trial from the Far East

2018 ◽  
Vol 10 (S33) ◽  
pp. S4162-S4164 ◽  
Author(s):  
Toni Lerut
2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 138-138
Author(s):  
A. Pisa ◽  
I. Moya ◽  
C. Pericay ◽  
E. Dotor ◽  
J. Alfaro ◽  
...  

138 Background: Surgery is considered the best treatment for patients (pts) with non-metastatic locally advanced squamous cell carcinoma of the esophagus who have responded to neoadjuvant chemoradiotherapy (CRT) in terms of locoregional control. However, in these pts PFS and OS have not been proved superior to those achieved by CRT alone. Besides, the addition of surgery to CRT increases treatment-related morbidity and mortality. Unfit pts are usually declined for surgical procedures and included in definitive CRT programs. The aim of this study was to define the role of non-surgical strategies (CRT, CT or RT) in unfit pts considered non-optimal for surgical procedures. Methods: We retrospectively reviewed 90 pts with squamous cell carcinoma of the esophagus who had been diagnosed and treated at our institution from January 2004 to December 2009. Fifty-one pts were non-metastatic among which 19 underwent surgery and 32 a non-surgical procedure (CRT, CT, RT or BSC). Our aim was to identify OS, PFS, RR, data on comorbidity and toxicity in these 32 pts. Results: Thirty out of the 32 pts were men with a median age of 62 years (range 41-90). Comorbidity was detected in 17 pts (53%) as means of respiratory disorders (21.9%), cardiopathy (12.5%), hepatopathy (21.9%), synchronic tumors (25%) and metachronic tumors (25%). Seventeen pts received CRT, 7 received CT, 1 received RT and 7 received BSC alone (53%, 22%, 3% and 22% respectively). Grade 3 and 4 toxicities were observed in 15 pts (46.9%) as means of mucositis (18.8%), oesophagitis (15.6%), diarrhoea (12.5%) and neutropaenia (12.5%). One patient in the CRT group died of toxicity. RR was 43.8% (70.6% for CRT, 14.3% for CT alone). Median follow-up was 17.2 months. Median PFS was 11.3 ± 6.12 months (17.9 for CRT, 5.1 for CT alone). Median OS was 15.6 ± 7.6 months (6.9 for CT alone). Conclusions: Our experience with CRT alone in unfit pts with locally advanced squamous cell carcinoma of the oesophagus supports its use with a median PFS of 17.9 months and controllable toxicity. Data on median OS are lacking due to pending long-term follow-up. No significant financial relationships to disclose.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4042-4042
Author(s):  
Ta-Chen Huang ◽  
Chia-Chi Lin ◽  
Kai-Yuan Tzen ◽  
Yun-Chun Wu ◽  
Jason Chia-Hsien Cheng ◽  
...  

4042 Background: The optimal use of the metabolic tumor response measured by 18fluorodeoxyglucose positron emission tomography (FDG-PET) in the treatment of esophageal cancer is currently unknown. We launched a phase II clinical trial to evaluate the early metabolic response to one-cycle chemotherapy in locally advanced esophageal squamous cell carcinoma (ESCC) patients, who subsequently received neoadjuvant chemoradiation (neo-CRT) followed by surgery. Methods: ESCC patients with stage T3 or N1M0 or M1a (AJCC, 6th edition) were enrolled to receive one-cycle chemotherapy, day 1 and 8 doses of paclitaxel, cisplatin, and 24-hour infusional 5-fluorouracil and leucovorin, followed by paclitaxel/cisplatin- based 40Gy neo-CRT and surgery. FDG-PET was performed at baseline and day 14 of the one-cycle chemotherapy. The primary endpoint is pathological complete response (pCR) to neo-CRT. We hypothesized that early PET responders, defined as > 35% reduction of maximum standardized uptake value (SUVmax) from the baseline, would significantly improve pCR. Results: Between Feb 2008 and Mar 2012, 66 patients (M: F = 61: 5) were enrolled. Their clinical stages were: II or III, 56; IVA, 10. Forty seven received surgery. The pCR rate per surgical population was 34.0%. The median progression-free survival (PFS) and overall survival (OS) for the whole study group was 16 months (95% CI 9-27) and 22 months (95% CI 16-40), respectively. A total of53 patients were evaluable for PET response. The early PET response was not associated with high pCR rate or better survivals. However, in an exploratory analysis, the post-chemotherapy SUVmax was an independent prognostic factor for pCR, PFS and OS. A predictive model for pCR composed of weight loss and the post-chemotherapy SUVmaxwas established with an AUC of 0.84. Conclusions: Our study failed to validate the predictive value of predefined early PET response to one-cycle chemotherapy for pCR to neo-CRT in locally advanced ESCC patients. However, the FDG-PET SUVmax after one-cycle chemotherapy may have prognostic and predictive significance, and may be explored in further studies. Clinical trial information: NCT01034332.


2014 ◽  
Vol 191 (2) ◽  
pp. 153-160 ◽  
Author(s):  
Arif Deniz Ordu ◽  
Carsten Nieder ◽  
Hans Geinitz ◽  
Philipp Günther Kup ◽  
Lisa Felicia Deymann ◽  
...  

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