PS02.116: FEASIBILITY OF DOCETAXEL, CISPLATIN, AND 5-FLUOROURACIL (DCF) VERSUS RADIOTHERAPY WITH DCF (DCF-RT) AS PREOPERATIVE THERAPY FOR LOCALLY ADVANCED ESOPHAGEAL CANCER

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 154-154
Author(s):  
Shoji Natsugoe ◽  
Ken Sasaki ◽  
Yasuto Uchikado ◽  
Hiroshi Okumura ◽  
Itaru Omoto ◽  
...  

Abstract Background In Japan, preoperative chemotherapy with cisplatin plus 5-fluorouracil (CF) followed by radical surgery has been accepted as the standard therapeutic approach for resectable esophageal squamous cell carcinoma (ESCC) result from a Japan Clinical Oncology Group randomized control trial. Whether preoperative chemoradiotherapy (CRT) followed by radical surgery is effective for Japanese ESCC patients has yet to be established. Some trials have reported usefulness of CF plus docetaxel therapy (DCF) for advanced or metastatic ESCC. Here, we have launched a randomized controlled trial to compare preoperative DCF versus DCF plus radiotherapy (DCF-RT) followed by surgery in locally advanced esophageal cancer. Methods Patients with clinical stage II/III (Japanese Classification of Esophageal Cancer, 11th Edition) are randomized to 2 groups. Patients in DCF group receive 2 courses of preoperative DCF (docetaxel, 60 mg/m2/day, day 1; cisplatin, 70 mg/m2/day, day 1; 5-FU, 700 mg/m2/day, days 1–5) repeated every 3 weeks. Patients in DCF-RT group receive preoperative chemoradiotherapy (40Gy/20fr) with 2 courses of DCF (docetaxel, 30 mg/m2/day, day 1, 15; cisplatin, 7 mg/m2/day and 5-FU, 350 mg/m2/day, days 1–5, days 8–12, days 15–19, days 22–26). The primary endpoint is overall survival and the secondary endpoints include adverse events, response rate and pathologic complete response rate. Results Twenty-seven patients were assigned to the DCF group and 26 patients to the DCF-RT group. Grade 3/4 leukopenia and febrile neutropenia occurred 37% and 19% in the DCF group, 35% and 12% in the DCF-RT group. The clinical response rates were 16.0% and 64.0% in the DCF and DCF-RT group. Twenty patients and 23 patients underwent surgery in the DCF and DCF-RT group, and the R0 resection rate was 80.0% and 91.3%. With regard to the surgical complications, the incidence of anastomotic leakage was significantly higher in the DCF-RT group compared with the DCF group. The histological effects of DCF-RT were significantly higher than those of DCF. Two-year survival rate was 46% in the DCF group and 70% in the DCF-RT group. Conclusion The DCF and DCF-RT were found to be feasible as neoadjuvant therapy, and DCF-RT demonstrated higher efficacy than DCF in clinical stage II/III esophageal cancer patients. Disclosure All authors have declared no conflicts of interest.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15559-e15559
Author(s):  
G. M. Videtic ◽  
H. M. Macley ◽  
C. Reddy ◽  
D. J. Adelstein ◽  
T. W. Rice ◽  
...  

e15559 Background: To assess the value of the primary tumor's SUVmax (PT-SUVmax) from the staging FDG-PET as a predictor of clinical and pathologic outcomes in patients undergoing trimodality therapy for locally advanced esophageal cancer. Methods: A retrospective chart review was conducted on patients with T3/4 and/or node positive esophageal carcinoma treated at the Cleveland Clinic between 7/1/03 and 5/31/06. All patients were managed with an institutional regimen consisting of preoperative radiotherapy [30 Gy @ 1.5 Gy twice daily over two weeks] with concurrent cisplatin and 5-fluorouracil during the first week. Following resection, an identical postoperative course of concurrent chemoradiotherapy (CRT) was delivered. Pretreatment patient and tumor characteristics including PT-SUVmax were analyzed with respect to response and survival. Results: 141 patients completed preoperative CRT: 125 (88.7%) were male, median age was 60 years, 73.8% had adenocarcinoma, 79.4% had N1 disease, 81.6% underwent surgery and 63.8% completed the full regimen. Median follow-up was 17.2 months [range 0.7–75.1]. Median PT-SUVmax was 9.43 [range 0 to 47.7]. Increasing clinical stage was associated with increasing PT-SUVmaxs: for cT2 vs. cT3 and cN0 vs. cN1, PT-SUVmax cutoffs were 8 (p=0.03) and 11 (p=0.02), respectively. Median (MST) and 5-year overall survivals were 20.7 months and 27.4%, respectively. A PT-SUVmax of < vs. > 7 was a significant predictor for T downstaging (p=0.0502) and N downstaging (p=0.0467). A PT-SUVmax cutoff of 7.6 was associated with a significant difference in MST, at 29.1 and 13.0 months for PT-SUVmax< 7.6 and >7.6, respectively (p=0.0158, HR=1.82, 95%CI=1.19–2.94). On multivariate analysis, PT-SUVmax was the only significant factor associated with survival (p=0.0.314, HR=1.71, 95%CI=1.05–2.79). Conclusions: The pretreatment SUVmax of a primary esophageal cancer appears to correlate with clinical stage, pathologic response to therapy and survival. This finding could play a role in the design of clinical trials and in adapting treatment strategies. No significant financial relationships to disclose.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15086-15086
Author(s):  
R. Diaz ◽  
G. Reynes ◽  
A. Tormo ◽  
A. Segura ◽  
A. Santaballa ◽  
...  

15086 Background: Concomitant chemoradiotherapy (CT-RT) with CDDP-5FU CT is a standard treatment in locally advanced esophageal cancer (EC). Long-term results are poor. The role of neoadjuvant CT (nCT) and of radical surgery after CT-RT is unclear. Methods: Single-institution, prospective trial in pts with stage II-IVA EC (TNM). PS 0–1. Staging: CT scan, barium x-ray, esophagoscopy and endoscopic ultrasound. Treatment schema: 1 cycle of neoadjuvant CT (CDDP 100 mg/m2 d1 and 5-FU 1,000 mg/m2/24 h d1–5); after 21 days, 50 Gy of RT (1.8 cGy/day, M to F) and 2 cycles of reduced-dose CT (CDDP 15 mg/m2 d1–5 and 5-FU 800 mg/m2/24 h d1–5, q21 days). In pts deemed resectable, surgery was done after 4–6 weeks. In the remainder, a 10 Gy boost was given with 1 cycle of modified CT. Primary endpoint: clinical and pathological response rate (RR) after 1st phase. Secondary endpoints: OS and toxicity rates. Results: 71 pts accrued between 1998 and 2006. Median age 61 yrs (r 44–80). 96% males. 85% squamous cell carcinomas. Middle third: 51%; upper third: 27%; lower third 22%. Gastric involvement: 11%. cT3: 46%, cT4: 28%. cN positive: 48%. Grade 3–4 toxicity with nCT and CT-RT: mucositis (9 and 19.5%), emesis (9 and 9%) and infection (6 and 9%). Full dose CT-RT: 87%. Clinical RR after 1st phase: CR 50%, PR 25%, SD 9%, PD 7%. Confirmation (CT- biopsy): 69%. Surgery: 30%. Reasons for no surgery: comorbidity (11%) and age (10%). Pathologic RR: CR 39%, microscopic rest 39% and macroscopic rest 22%. Downstaging 50%. No pN positive. 3 pts had unresectable disease. 62% received 2nd phase RT boost, 31% with CT. Clinical RR: CR 69%, PR 6%, PD 25%. Median follow-up 50 m (r 6–129 m). Median OS 10.5 m (r 7.4–12.8 m). 4-year OS of 18%. 47% deaths due to progression, 5% treatment-related deaths and 10% in the postoperative period. Only a clinical CR after 1st phase was found to improve OS (13.5 vs 7 m, p 0.0141). Conclusions: This regimen is well tolerated and offers a high response rate. Clinical response evaluation overestimates the pathologic response rate. In our series, the possible survival benefit of surgery is offset by the postoperative death rate. No significant financial relationships to disclose.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 144-144
Author(s):  
Divya Yerramilli ◽  
Davendra Sohal ◽  
Ursina R. Teitelbaum ◽  
Paul Stephen Wissel ◽  
Nevena Damjanov ◽  
...  

144 Background: The benefit of adjuvant chemotherapy after preoperative chemoradiation and surgery is unclear in patients with locally advanced esophageal cancer. We studied the toxicities and clinical outcomes in patients treated with or without adjuvant chemotherapy (CTX) after trimodality therapy. Methods: Records of patients with T3+ or N+ esophageal cancer who received preoperative chemoradiation followed by surgical resection from 2003-2013 were reviewed. Patients with postoperative deaths or poor performance status within 3 months after surgery were excluded (n = 13). Tolerability and hematologic toxicities of adjuvant CTX were recorded. Clinical outcomes of patients treated with adjuvant CTX were compared with a cohort of patients who received no further therapy (NFT). Results: Of the 81 trimodality patients included in the study, 53 received CTX and 28 received NFT after surgery. Median follow-up time was 23 months. FOLFOX (34%), cisplatin/5-FU (15%), 5-FU/LV (15%), ECF (13%), and carboplatin/paclitaxel (9%) were the most commonly used adjuvant regimens. Multiple rationales for adjuvant CTX were cited, including pathologic nodal status (32%), favorable pathologic response (61%), and provider preference (51%). Grade III/IV hematologic toxicity occurred in 11% of the CTX group: leukopenia (8%/2%), neutropenia (4%/4%), and thrombocytopenia (2%/0%). Two patients in the CTX group did not complete their prescribed CTX, which was discontinued after 1 cycle. Patient and clinical characteristics between CTX and NFT patients were well-balanced, except for pathologic complete response (pCR) rates (CTX 25% vs. NFT 50%, p=0.03). Three-year OS and DFS were similar between CTX and NFT patients (74% vs 70%, 60% vs. 64%, respectively). In patients who achieved pCR (33% overall), adjuvant CTX was associated with an improved 3-yr OS (86% vs. 62%), but the difference did not reach statistical significance (p=0.22). Distant failures occurred in 11% of the CTX group and 18% of the NFT group. Conclusions: Adjuvant CTX after trimodality therapy in esophageal cancer is feasible and well-tolerated with encouraging clinical outcomes. Further studies are needed to define the role of adjuvant CTX in these patients.


2020 ◽  
Vol 38 (23) ◽  
pp. 2677-2694 ◽  
Author(s):  
Manish A. Shah ◽  
Erin B. Kennedy ◽  
Daniel V. Catenacci ◽  
Dana C. Deighton ◽  
Karyn A. Goodman ◽  
...  

PURPOSE To develop an evidence-based clinical practice guideline to assist in clinical decision making for patients with locally advanced esophageal cancer. METHODS ASCO convened an Expert Panel to conduct a systematic review of the more recently published literature (1999-2019) on therapy options for patients with locally advanced esophageal cancer and provide recommended care options for this patient population. RESULTS Seventeen randomized controlled trials met the inclusion criteria. Where possible, data were extracted separately for squamous cell carcinoma and adenocarcinoma. RECOMMENDATIONS Multimodality therapy for patients with locally advanced esophageal carcinoma is recommended. For the subgroup of patients with adenocarcinoma, preoperative chemoradiotherapy or perioperative chemotherapy should be offered. For the subgroup of patients with squamous cell carcinoma, preoperative chemoradiotherapy or chemoradiotherapy without surgery should be offered. Additional subgroup considerations are provided to assist with implementation of these recommendations. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .


2009 ◽  
Vol 56 (4) ◽  
pp. 83-89
Author(s):  
Ljiljana Radosevic-Jelic ◽  
V. Stankovic ◽  
T. Josifovski ◽  
V. Nikolic ◽  
I. Popov ◽  
...  

Preoperative or definitive chemoradiotherapy defines today the standard treatment of patients with localized or locally advanced esophageal cancer. Preliminary results of our study are presented. 46 patients with locally advanced squamous cell esophageal cancer (T3-4, N0-1, M0) were enrolled. All patients recieved concomitant chemotherapy (Cisplatin/ 5FU/LV) and radiotherapy (45-50,4Gy). Clinical response rate was 59% (3 patients (7%) complete response, 24 patients (52%) partial regression, 13 (28%) stabile disease, 6 patients (13%) disease progression). Out of 46 patients, 12 were operated (26%), all with R0 resection. Complete patohistolgical regression (TRG 1) was noted in 5 patients (42%). TRG 2 i TRG 3 in one (8%) and 3 patients (25%), and TRG 4 in 3 patients (25%). Mean survival time in operated group of patients was 9,3 months, and in nonoperated group 5,5 months. Studies show improved survival rate in patients with complete response to chemoradiotherapy and R0 resection. Individualy tailored therapy is essential.


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