scholarly journals Gross Tumor Volume as Influencing Pathological Complete Response Factor After Neoadjuvant Chemoradiation in Locally Advanced Rectal Adenocarcinoma Patients

Author(s):  
M. Lutsyk ◽  
K. Gourevich ◽  
R. Ben Yosef
2018 ◽  
Vol 36 (4_suppl) ◽  
pp. TPS879-TPS879
Author(s):  
Ramakrishnan Ayloor Seshadri ◽  
Trivadi S. Ganesan ◽  
Arunkumar M N ◽  
Shirley Sundersingh

TPS879 Background: Patients with rectal cancers treated with neoadjuvant chemoradiation followed by surgery and adjuvant chemotherapy are not exposed to systemic doses of chemotherapy until very late in the treatment schedule. Preoperative chemotherapy, either in the neoadjuvant or interval setting can lead to early treatment of micrometastasis, improve the tumor response and possibly the overall survival. Phase II studies of neoadjuvant chemotherapy in rectal cancer have shown good response to chemotherapy with no tumor progression and good compliance. A phase II study evaluating the effect of giving chemotherapy in the interval waiting period between chemoradiation and surgery has shown acceptable toxicity and high pathological complete response rates. Methods: This single centre, randomized, open label, phase II trial compares the safety and efficacy of two pre-operative regimens in locally advanced MRI defined high-risk rectal cancers. Based on the Simon optimal two-stage design, 94 patients will be randomised to either Arm A [3 cycles of neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by chemoradiation (50.4 Gy with capecitabine) and then surgery] or Arm B [neoadjuvant chemoradiation followed by 3 cycles of interval chemotherapy and then surgery]. Patients in both arms receive 3 cycles of adjuvant chemotherapy. The primary end-point is the pathological complete response rate. Secondary end-points include frequency and severity of adverse events, RO resection rates, tumor regression grading and compliance to treatment. The inclusion criteria: age 18 to 70 years; ECOG performance status 0-2; non-metastatic, locally advanced rectal cancer with any one of the following features on high-resolution thin slice MRI: any T3/T4 tumor in the lower rectum, T3c/T3d/T4 tumor in the mid rectum, N2 disease, threatened mesorectal fascia, or extramural vascular invasion. Patients are randomly assigned to one of the two intervention arms in a 1:1 ratio. Prespecified activity goal for the first stage of accrual was met; second stage accrual began in July 2017. Clinical trial information: CTRI/2015/01/005385.


2014 ◽  
Vol 23 (2) ◽  
pp. 171-178 ◽  
Author(s):  
Zsolt Fekete ◽  
Alina-Simona Muntean ◽  
Stefan Hica ◽  
Alin Rancea ◽  
Liliana Resiga ◽  
...  

Background & Aims: The purpose of this prospective observational study was to evaluate the rate andthe prognostic factors for down-staging and complete response for rectal adenocarcinoma after inductionchemotherapy and neoadjuvant chemoradiation followed by surgery, and to analyze the rate of sphinctersaving surgery.Methods: We included from March 2011 to October 2013 a number of 88 patients hospitalized with locally advanced rectal adenocarcinoma in the Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj. The treatment schedule included 2-4 cycles of Oxaliplatin plus a fluoropyrimidine followed by concomitant chemoradiation with a dose of 50 Gy in 25 fractions combined with a fluoropyrimidine monotherapy.Results:The rate of T down-staging was 49.4% (40/81 evaluable patients). Independent prognostic factors for T down-staging were: age >57 years (p<0.01), cN0 (p<0.01), distance from anal verge >5 cm (p<0.01), initial CEA <6.2 ng/ml (p<0.01), higher number of chemotherapy cycles with Oxaliplatin (pROC=0.05) and protraction of radiotherapy of >35 days (p<0.01). Nine patients from 81 (11.1%) presented complete response (7 pathological and 2 clinical); the independent prognostic factors were stage cT2 versus cT3-4 (p<0.01), initial tumor size ≤3.5 cm and distance from anal verge >5 cm (p=0.03). Sixty-eight patients (79.1%) underwent radical surgery and among them 35 patients (51.5 %) had a sphincter saving procedure.Conclusions: Induction chemotherapy with neoadjuvant chemoradiation produced important down-staging in rectal adenocarcinoma. Independent prognostic factors for T down-staging were: age, cN0, distance from anal verge, initial CEA, the number of Oxaliplatin cycles and duration of radiotherapy; for complete response: cT2, initial tumor size and distance from the anal verge. Abbreviations: 5FU: 5-fluorouracil; AJCC: American Joint Committee on Cancer; AV: anal verge; CAPOX: Capecitabine plus Oxaliplatin; CCR: clinical complete response; CRT: chemoradiation; CTC4.0: Common Terminology Criteria for Adverse Events, version 4.0; ECOG: Eastern Collaborative Oncology Group; EUS: endorectal ultrasound; FOLFOX: 5-fluorouracil plus Oxaliplatin; LARC: locally advanced rectal cancer; PCR: pathological complete response; PS: performance status; PTV: planning target volume; R0: Resection, 0 (microscopically clear resection margin); ROC curve: receiver operating characteristic curve; TME: total mesorectal excision; TRG: tumor regression grade.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 155-155
Author(s):  
Roberto Innocente ◽  
Federico Navarria ◽  
Elisa Palazzari ◽  
Fabio Matrone ◽  
Eleonora Farina ◽  
...  

Abstract Background Evaluate safety, feasibility and efficacy of an intesified IMRT and concomitant carboplatin and paclitaxel-based chemotherapy (Carbo/Tax CT) in patients (pts) with locally advanced esophageal cancer (LAEC) treated at our Institution Methods We retrospectively analyzed acute toxicity (according to CTCAE 4.0 scale), compliance and response to treatment in a series of consecutive patients treated, between February 2016 and February 2018, with intensified radiotherapy (IMRT) and weekly concurrent carboplatin and paclitaxel-based chemotherapy (CT) according to the CROSS trial. Results Thirty-four consecutive pts, 30(88%) males and 4 (12%) females, were treated. The median age was 68.5 yrs (range 46–83) and the ECOG Performance status ranged from 0 to 2. The diagnosis was adenocarcinoma in 15 pts (44%), squamous-cell carcinoma in 18 pts (53%) and undifferentiated carcinoma in 1 pt (3%). Two pts (6%) had a T2, 26 pts (76.4%) a T3 and 6 pts (17.6%) a T4 disease, respectively; 5 pts (15%) were N0, 21 pts (62%) N1 and 8 pts (23%) N2, respectively. Tumor involved the cervical esophagus in 3 pts (9%), the thoracic esophagus in 24 pts (70.5%) and the gastroesophageal junction in 7(20.5%). All pts underwent concurrent chemoradiotherapy (CRT), with IMRT technique, consisting of 45 Gy/25 frs to PTV1 (the primary gross tumor volume and the regional nodes), a simultaneous integrated boost ranging from 52.5Gy to 54Gy to PTV2 (gross tumor volume) and weekly concurrent carboplatin (AUC2) and paclitaxel (50mg/m2). Induction CT was administered to 6 pts. All pts completed the RT schedule. The median number of CT cycles was 3 (range 1–5) and 11 pts (32%) received 4 to 5 cycles of CT. Two adverse reactions to paclitaxel were reported. There were no major non-hematological adverse effects, the most common were nausea and vomiting (10%), and dysphagia (7%). Leukopenia was reported in 20 pts (71%), G3 in 2 pts (10%) and G2 in 18 (90%), respectively. G2 anemia occurred in 2 pts while G2 thrombocytopenia was reported in 3 pts (10%). Among the 30 evaluable pts (restaging is ongoing in 4 pts) a clinical complete response (PET, endoscopy and biopsy) was observed in 11 pts (37%), 7 with adenocarcinom and 4 with squamous cell carcinoma. Partial response was observed in 11 pts (37%) and 8 (26%) showed progressive disease. Total esophagectomy with radical lymphadenectomy, performed in 11 pts, showed a pathologic complete response in 6 pts (54%). Conclusion Intensified IMRT with concomitant Carbo/Tax CT in pts with LAEC seems to be safe and effective. These promising results need to be confirmed in all pts evaluated in this multimodality program Disclosure All authors have declared no conflicts of interest.


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