scholarly journals Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E

2008 ◽  
Vol 2 ◽  
pp. CMO.S444
Author(s):  
Rajini Katipamula ◽  
Aminah Jatoi ◽  
Nathan R. Foster ◽  
Francis Nichols ◽  
Joseph Rubin ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Adverse Event ◽  
Treatment Group ◽  
Locally Advanced ◽  
Pathologic Response ◽  
Advanced Esophageal Cancer ◽  
North Central ◽  
Toxicity Analysis ◽  
Grade 3 ◽  
Locally Advanced Esophageal Cancer

Purpose This brief report describes a planned, interim, 6-patient toxicity analysis that confirms the safety of pemetrexed, carboplatin, radiation with subsequent surgery, as prescribed in the North Central Cancer Treatment Group trial N044E, in patients with locally advanced esophageal cancer. Methods Six patients with locally advanced, potentially resectable esophageal cancer received pemetrexed 500 mg/m2 and carboplatin AUC = 6 on days 1 and 22 with 5040 centigray of concomitant radiation in 28 fractions over 5.5 weeks followed by esophagectomy as a prelude to a phase II multi-institutional trial. Results Only 1 of the 6 patients experienced a grade 4 adverse event (neutropenia). This patient also experienced a grade 3 depression. Of the remaining 5 patients, three experienced at least one grade 3 adverse event (neutropenia, nausea/vomiting, and esophagitis). There were no deaths. Incidentally, one patient manifested a complete pathologic response, three a partial pathologic response, and one stable disease. Conclusion These preliminary observations on safety suggest that this regimen can be further studied in this clinical setting.

Neoadjuvant and combined chemoradiotherapy followed by surgery in locally advanced esophageal cancer: A single-centre experience

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15086-15086
Author(s):  
R. Diaz ◽  
G. Reynes ◽  
A. Tormo ◽  
A. Segura ◽  
A. Santaballa ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Response Rate ◽  
Locally Advanced ◽  
Prospective Trial ◽  
High Response Rate ◽  
Long Term Results ◽  
Advanced Esophageal Cancer ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Locally Advanced Esophageal Cancer

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.

Concurrent chemoradiotherapy with protracted infusion of 5-fluorouracil (5 FU) and cisplatin for locally advanced resectable esophageal cancer: A retrospective study.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 119-119
Author(s):  
Khaldoun Almhanna ◽  
Sarah Hoffe ◽  
Ravi Shridhar ◽  
Jonathan R. Strosberg ◽  
William R. Dinwoodie ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Surgical Resection ◽  
Locally Advanced ◽  
Complete Response ◽  
R0 Resection ◽  
Severe Toxicity ◽  
Advanced Esophageal Cancer ◽  
Resectable Esophageal ◽  
Grade 3 ◽  
Locally Advanced Esophageal Cancer

119 Background: Neoadjuvant CCRT has become the standard treatment for esophageal cancer. Most clinicians use a conventional cisplatin/5 FU combination which is associated with moderate to severe toxicity. For the last 15 years we have used contiuous low-dose 5-FU combined with two doses of cisplatin. Methods: Between July 1997 and June 2012, 155 patients with locally advanced esophageal cancer (T3 or N1 and higher), received CCRT consistent of cisplatin 75 mg/m2 on day 1 and day 29 and continuous infusion of 5-FU (225 mg/m2/day) on the days of radiation. Results: Median age of patients was 63 year (30-76).Seventeen percent of pts were female and 85% had adenocarcinoma. (3, 34, 86 and 31 pts had stage I, II, III and IVa disease respectively. One hundred and twenty seven pts had N1 disease. Radiation dose (RT) ranged from 45-60 Gy (median 56Gy). Median weight loss was 6.5%. All patients completed treatment. 20% of patients had >=grade 3 toxicity, with 29 patients requiring hospital admission. 53% of patients had surgical resection between 37-149 days following CCRT (median 62 days). R0 resection was achieved in 96% of patients. A pathological complete response was achieved in 38 of 83 pts (45%) who underwent surgical resection. With a median follow up of 26 months (1.2 -144 months), 36% of pts recurred and total of 50% died. Conclusions: Compared to conventional chemotherapy regimen, our CCRT regimen for locally advanced esophageal cancer is well tolerated and associated with a high pathological response rate.

Multimodality therapy for locally advanced esophageal cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 211-211
Author(s):  
Nitesh N. Paryani ◽  
Stephen Ko ◽  
Corey James Hobbs ◽  
Kristin Kowalchik ◽  
Elizabeth Johnson ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Acute Toxicity ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Advanced Esophageal Cancer ◽  
Current Standard ◽  
Grade 3 ◽  
Experienced Grade ◽  
Locally Advanced Esophageal Cancer

211 Background: The current standard of care for locally advanced esophageal cancer includes chemoradiotherapy with or without surgery. Radiation is usually delivered via a 3D technique. IMRT has been utilized in the treatment of multiple tumors and demonstrated similar efficacy while offering the possibility of decreased toxicity. Methods: Thirty-six patients were treated with IMRT and chemotherapy. Twenty-one patients underwent surgical resection. Eleven underwent open surgery and the remainder underwent minimally invasive surgery. Chemotherapy consisted primarily of 5-FU with oxaliplatin or cisplatin. All but two patients received 50.4 Gy; one patient received 41.4 Gy without surgery and one patient discontinued treatment after 25.2 Gy. Eleven patients required a treatment break during radiotherapy. The median age was 69 (range 46-87). Approximately two-thirds of tumors were adenocarcinomas located in the lower thorax. Two thirds of patients were staged as T3 and had positive lymph nodes. The median tumor size was 5 cm (range 2-13). Results: With a median follow-up of 21.3 months (range 2.4-44.8) and 33.9 months for survivors (range 3.7-44.8), overall survival at 24 months was 55%. The 24 month overall survival was 75% vs 24% for surgical and non-surgical patients, respectively. Seven patients had a complete pathologic response. Twenty-four patients experienced grade 3 or higher acute toxicity and there was one grade 5 toxicity. Acute toxicity was similar between surgery and non-surgery patients. Fourteen patients experienced grade 3 or higher late toxicity; 9 surgery and 5 non-surgery patients. The most frequent late toxicity was grade 3 stricture (21%). On multivariate analysis, advanced age (RR [10 year increase] 2.01, p=0.032) and heart maximum dose >55 Gy (RR 3.73, p=0.011) were associated with decreased survival. Conclusions: Patients who undergo surgery after chemoradiotherapy demonstrate improved survival; however, this may be related to underlying comorbidities that preclude surgery. IMRT appears to be a reasonable treatment option that may reduce complications from radiotherapy. Careful attention should be given to heart dose during treatment planning.

scholarly journals Toripalimab Used on the Same Day or Third Day With Chemotherapy for Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer—A Phase II Study

2021 ◽  
Author(s):  
Wenqun Xing ◽  
Lingdi Zhao ◽  
Yan Zheng ◽  
Baoxing Liu ◽  
Xianben Liu ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Control Group ◽  
Advanced Esophageal Cancer ◽  
Grade 3 ◽  
Experimental Group ◽  
Locally Advanced Esophageal Cancer

Abstract Background There is no standard neoadjuvant therapy for locally advanced esophageal cancer in China. The role of neoadjuvant chemotherapy plus immunotherapy for locally advanced esophageal cancer is still being explored. Methods This open-label, randomized phase II study was conducted at a single center between July 2019 and September 2020, 30 patients with locally advanced ESCC (T3, T4, or lymph-node positive) were enrolled. Patients were randomized according to the enrollment order at a 1:1 ratio to receive chemotherapy on day 1 and toripalimab on day 3 (experiment group) or chemotherapy and toripalimab on day 1 (control group). The chemotherapeutic regimen was paclitaxel and cisplatin. Surgery was performed 4 to 6 weeks after the second cycle of chemoimmunotherapy. The primary endpoint was pCR rate, the secondary endpoint were safety and disease-free survival. Results Thirty patients completed at least one cycle of chemoimmunotherapy; 11 in the experimental group and 13 in the control group received surgery. R0 resection was got in all these 24 patients. Four patients (36%) in the experimental group and one (7%) in the control group achieved pCR. The experimental group showed a statistically non-significant higher pCR rate (P = 0.079). PD-L1 combined positive score (CPS) examination was performed in 14 patients; one in control group had a PD-L1 CPS of 10 and pCR was achieved, while the left 13 were all ≤ 1, 11 of the 13 patients received surgery in which two (in the experimental group) got pCR. Two patients endured from ≥ grade 3 adverse events, one suffered from grade 3 immune-related enteritis after one cycle of chemoimmunotherapy and dropped off the study. Another patient died from severe pulmonary infection and troponin elevation after surgery. CONCLUSIONS Although the primary endpoint was not met, initial results of this study showed that delaying toripalimab to day 3 in chemoimmunotherapy might achieve a higher pCR rate than that on same day, and further large-sample clinical trials are needed to verify this. Trial registration: NCT 03985670, registered 10 June 2019.

Chemoradiotherapy for locally advanced esophageal cancer using carboplatin, paclitaxel.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14666-e14666
Author(s):  
Jodie E. Battley ◽  
Margaret O'Keeffe ◽  
Erica Mulvihill ◽  
Seamus O'Reilly ◽  
Michael William Bennett ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Locally Advanced ◽  
Squamous Carcinoma ◽  
Lymph Node Involvement ◽  
Advanced Esophageal Cancer ◽  
Grade 3 ◽  
Repeat Imaging ◽  
Locally Advanced Esophageal Cancer ◽  
Group Grade

e14666 Background: Localized esophageal adenocarcinoma is usually treated with multi-modality therapy, i.e., chemotherapy or chemoradiotherapy (CRT) followed by surgery. Standard treatment for localized squamous cell carcinoma is controversial as definitive CRT can offer the same overall survival as CRT followed by surgery. Cisplatin and infusional 5FU is the accepted chemotherapy in combination with RT. However this regimen is cumbersome to administer and is associated with significant toxicities. Based on recent data combining weekly paclitaxel with radiotherapy in both the neoadjuvant and definitive settings we report our early experience with this regimen. Methods: All patients (pts) were staged with CT, EUS and PET/CT. Pts with localized, operable or inoperable disease were included. CRT consisted of paclitaxel 50mg/m2 and carboplatin AUC = 2 on days 1, 8, 15, 22, 29, 35 with concurrent RT (5 days/wk, 41.4-50.4Gy). Results: From December 2010 to January 2012, 24 pts: male/female 20/4, median age 67 yrs (29-88), adeno/squamous carcinoma 14/10, lymph node involvement (21pts) were treated. 13 pts treated with neoadjuvant (NA) intent, 11 pts underwent definitive CRT. In the NA group grade 3/4 toxicities were non-hematologic: cardiac (1pt), fatigue (1pt), 2 pts died from progression of disease prior to surgery. Eight pts have undergone surgery (3 awaited). RO resection rate 87.5%, 1 pt had a pCR, 4 pts had a near pCR. At 3mth follow-up 3 pts had no clinical or radiological evidence of disease, 5 pts await repeat imaging. In the definitive group grade 3/4 toxicities included hematologic: neutropenic fever (1pt), non-hematologic: esophagitis (3pts). At 3mth follow-up 7 pts have stable disease, 4 pts await repeat imaging. Dysphagia improved in 21 pts, worsened in 3 pts, and 5 pts required a feeding tube (4 prior to CRT). Conclusions: Carboplatin and paclitaxel combined with radiotherapy is a tolerable regimen in either the neo-adjuvant or definitive setting for locally advanced esophageal cancer. Rates of toxicity compare favorably to standard cisplatin and infusional 5FU. Prospective data with long-term follow-up using this regimen have been reported in the neo-adjuvant setting and are awaited in the definitive setting.

scholarly journals The Sequence of Chemotherapy and Toripalimab Might Influence the Efficacy of Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer—A Phase II Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Wenqun Xing ◽  
Lingdi Zhao ◽  
Yan Zheng ◽  
Baoxing Liu ◽  
Xianben Liu ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Squamous Cell ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Control Group ◽  
Advanced Esophageal Cancer ◽  
Grade 3 ◽  
Experimental Group ◽  
Locally Advanced Esophageal Cancer

BackgroundThere is no standard neoadjuvant therapy for locally advanced esophageal cancer in China. The role of neoadjuvant chemotherapy plus immunotherapy for locally advanced esophageal cancer is still being explored.MethodsThis open-label, randomized phase II study was conducted at a single center between July 2019 and September 2020; 30 patients with locally advanced esophageal squamous cell carcinoma (ESCC) (T3, T4, or lymph-node positive) were enrolled. Patients were randomized according to the enrollment order at a 1:1 ratio to receive chemotherapy on day 1 and toripalimab on day 3 (experimental group) or chemotherapy and toripalimab on day 1 (control group). The chemotherapeutic regimen was paclitaxel and cisplatin. Surgery was performed 4 to 6 weeks after the second cycle of chemoimmunotherapy. The primary endpoint was pathological complete response (pCR) rate, and the secondary endpoint was safety and disease-free survival.ResultsThirty patients completed at least one cycle of chemoimmunotherapy; 11 in the experimental group and 13 in the control group received surgery. R0 resection was performed in all these 24 patients. Four patients (36%) in the experimental group and one (7%) in the control group achieved pCR. The experimental group showed a statistically non-significant higher pCR rate (p = 0.079). PD-L1 combined positive score (CPS) examination was performed in 14 patients; one in the control group had a PD-L1 CPS of 10, and pCR was achieved; the remaining 13 all had ≤1, and 11 of the 13 patients received surgery in which two (in the experimental group) achieved pCR. Two patients endured ≥grade 3 adverse events, and one suffered from grade 3 immune-related enteritis after one cycle of chemoimmunotherapy and dropped off the study. Another patient died from severe pulmonary infection and troponin elevation after surgery.ConclusionsAlthough the primary endpoint was not met, the initial results of this study showed that delaying toripalimab to day 3 in chemoimmunotherapy might achieve a higher pCR rate than that on the same day, and further large-sample clinical trials are needed to verify this.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT 03985670.

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