Induction chemotherapy (ICT) followed by pre-operative chemoradiotherapy in locally advanced rectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13531-13531
Author(s):  
Y. Elkerm ◽  
M. Elrewiny ◽  
S. Al-Batran ◽  
E. Jager ◽  
A. Elsaid
Keyword(s):  
Tumor Regression ◽  
Randomized Study ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
R0 Resection ◽  
Low Toxicity ◽  
Delayed Complications ◽  
Pathological Cr

13531 Background: Preoperative radiotherapy (RT)with or without chemotherapy (CRT) for patients (ptns) with T3,4 rectal carcinoma is increasingly accepted.We presented, 3 yrs ago, our experience with Cisplatin-5FU-Folonic(FA)regimen (FOLFC) in patns with metastatic CR carcinoma.We proved it is comparable to other regimens with lower cost. Methods: Between 10/99 & 8/04, 104 ptns between 18 and 65 year old (PS 0–1) were assessed retrospectively (24 T3 & 80 T4). Ptns received 2 months of ICT Cis(40mg/m2 D1)+FA(200mg/m2 2hrs infusion D1,2)followed by 5FU bolus(400 mg/m2 D1,2)+5FU cont inf(1200 mg/m2 D1–2)this cycle repeated q 2 wks for 8 wks. Starting on wk 9, 5 FU-FA was given as in Mayo-clinic regimen (D1–5, D21–25) with concomitant RT 45Gy in 25 fractions followed by 9 Gy boost to primary tumor. TME was planned at 4–6 wks from completion of ICT. 2 more cycles of FOLFC was given post-operatively. Results: All ptns (104) undergoing CRT completed therapy as planned, with no treatment-related interruptions. No GIII-IV toxicity. The radiological RR (after ICT) was 75% and (4 wks after CRT) was 89% (20CRs, 73PRs). 92% of ptns had subjective R in a median of 24 days from start of ICT in terms of improvement of diarrhea/constipation (90.4%), in obstructive symptoms (40/ 50 ptns)&weight gain in 100% of ptns.Reduced rectal bleeding (100%) & pelvic pain (100%). 17 of 20 ptns who were considered to be inoperable prior to the treatment underwent TME with negative radial margins. Anastomotic leakage occurred in 8 ptns (7.7%). Wound infection occurred in 4 ptns (3.8%). Delayed complications occurred in 3 ptns one required surgery for a stomal stricture. All ptns underwent R0 resection with clear CRM. Pathological CR was found in 32 ptns and in an additional 41 ptns, only microscopic tumor foci were found on surgical specimens. After a median follow-up of 16 months, two ptns had developed LR. Conclusions: ICT followed by synchronous CRT and TME results in marked tumor regression, rapid symptomatic response and achievement of R0 resection. The majority of ptns considered inoperable prior to receiving this treatment underwent successful excision. Given the low toxicity and promising activity, this regimen is being compared to standard synchronous 5FU- pelvic chemoradiation in a randomized study. No significant financial relationships to disclose.

Phase II, Randomized Study of Concomitant Chemoradiotherapy Followed by Surgery and Adjuvant Capecitabine Plus Oxaliplatin (CAPOX) Compared With Induction CAPOX Followed by Concomitant Chemoradiotherapy and Surgery in Magnetic Resonance Imaging–Defined, Locally Advanced Rectal Cancer: Grupo Cáncer de Recto 3 Study

2010 ◽  
Vol 28 (5) ◽  
pp. 859-865 ◽  
Author(s):  
Carlos Fernández-Martos ◽  
Carles Pericay ◽  
Jorge Aparicio ◽  
Antonieta Salud ◽  
MariaJose Safont ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Regression ◽  
Randomized Study ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Phase Iii ◽  
R0 Resection ◽  
Concomitant Chemoradiotherapy

Purpose The optimal therapeutic sequence of the adjuvant chemotherapy component of preoperative chemoradiotherapy (CRT) for patients with locally advanced rectal cancer is controversial. Induction chemotherapy before preoperative CRT may be associated with better efficacy and compliance. Patients and Methods A total of 108 patients with locally advanced rectal cancer were randomly assigned to arm A—preoperative CRT with capecitabine, oxaliplatin, and concurrent radiation followed by surgery and four cycles of postoperative adjuvant capecitabine and oxaliplatin (CAPOX)—or arm B—induction CAPOX followed by CRT and surgery. The primary end point was pathologic complete response rate (pCR). Results On an intention-to-treat basis, the pCR for arms A and B were 13.5% (95% CI, 5.6% to 25.8%) and 14.3% (95% CI, 6.4% to 26.2%), respectively. There were no statistically significant differences in other end points, including downstaging, tumor regression, and R0 resection. Overall, chemotherapy treatment exposure was higher in arm B than in arm A for both oxaliplatin (P < .0001) and capecitabine (P < .0001). During CRT, grades 3 to 4 adverse events were similar in both arms but were significantly higher in arm A during postoperative adjuvant CT than with induction CT in arm B. There were three deaths in each arm during the treatment period. Conclusion Compared with postoperative adjuvant CAPOX, induction CAPOX before CRT had similar pCR and complete resection rates. It did achieve more favorable compliance and toxicity profiles. On the basis of these findings, a phase III study to definitively test the induction strategy is warranted.

A multicenter phase II study on the feasibility and efficacy of neoadjuvant chemotherapy for locally advanced rectal cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 730-730 ◽  
Author(s):  
Saori Goto ◽  
Suguru Hasegawa ◽  
Takuya Matsumoto ◽  
Koya Hida ◽  
Junichiro Kawamura ◽  
...  
Keyword(s):  
Response Rate ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
R0 Resection ◽  
Wild Type ◽  
Resection Rate ◽  
Postoperative Complication Rate ◽  
Pathological Cr

730 Background: The aim of this prospective multi-center phase II study was to evaluate the feasibility and efficacy of neoadjuvant chemotherapy (NAC) for locally advanced rectal cancer (LARC). Methods: Patients with LARC (cStage II–III) were included; those with cT4b tumor were excluded. Six cycles of mFOLFOX6 plus either bevacizumab (bev) or cetuximab (cet), depending on KRAS status, were administered before surgery. Primary endpoint was R0 resection rate. Secondary endpoints included completion rate of NAC, response rate, postoperative complications, pathological complete response (CR) rate, overall and disease-free survival, and quality of life. Results: Sixty patients from 7 institutes were enrolled. mFOLFOX6 was administered with bev to 40 patients who had wild-type KRAS and with cet to 20 patients who had K-RAS mutations. Completion rate of NAC was 88.4% and overall response rate was 81.7%. Sphincter-preserving surgery and abdominoperineal resection were performed in 43 and 17 patients, respectively. Median operation time was 335 min and median blood loss was 40 g. R0 resection rate was 98.3% and pathological CR rate was 16.7%. Overall postoperative complication rate ( ≥ grade 2) was 21.7%, including anastomotic leakage (11.6%), surgical site infection (6.7%), and urinary dysfunction (3.3%). There were no significant differences between patients with wild-type KRAS and those with KRAS mutations in response rate, postoperative complication rate, and pathological CR rate. Conclusions: NAC was a feasible and promising treatment option for LARC. Clinical trial information: UMIN000005654.

scholarly journals Radiotherapy Scheme Effect on PD-L1 Expression for Locally Advanced Rectal Cancer

Cells ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. 2071
Author(s):  
Jihane Boustani ◽  
Valentin Derangère ◽  
Aurélie Bertaut ◽  
Olivier Adotevi ◽  
Véronique Morgand ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Regression ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Tumor Regression Grade ◽  
The Impact

In locally advanced rectal cancer, radiotherapy (RT) followed by surgery have improved locoregional control, but distant recurrences remain frequent. Although checkpoint inhibitors have demonstrated objective response in several cancers, the clinical benefit of PD-1/PD-L1 blockade remains uncertain in rectal cancer. We collected data from biopsies and surgical specimens in 74 patients. The main objective was to evaluate the impact of neoadjuvant RT and fractionation on PD-L1 expression. Secondary objectives were to study the relation between PD-L1 expression and tumor regression grade (TRG), progression-free survival (PFS), overall survival (OS), and CD8 TILs infiltration. Median rates of cells expressing PD-L1 pre- and post-RT were 0.15 (range, 0–17) and 0.5 (range, 0–27.5), respectively (p = 0.0005). There was no effect of RT fractionation on PD-L1+ cell rates. We found no relation between CD8+ TILs infiltration and PD-L1 expression and no difference between high-PD-L1 or low-PD-L1 expression and TRG. High-to-high PD-L1 expression profile had none significant higher OS and PFS compared to all other groups (p = 0.06). Median OS and PFS were higher in biopsies with >0.08 PD-L1+ cells. High-to-high PD-L1 profile and ypT0-2 were significantly associated with higher OS and PFS. This study did not show the differential induction of PD-L1 expression according to fractionation.

scholarly journals Delta Radiomics Can Predict Distant Metastasis in Locally Advanced Rectal Cancer: The Challenge to Personalize the Cure

2020 ◽  
Vol 10 ◽  
Author(s):  
Giuditta Chiloiro ◽  
Pablo Rodriguez-Carnero ◽  
Jacopo Lenkowicz ◽  
Calogero Casà ◽  
Carlotta Masciocchi ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Distant Metastasis ◽  
Confusion Matrix ◽  
External Validation ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Features Selection ◽  
Testing Data

PurposeDistant metastases are currently the main cause of treatment failure in locally advanced rectal cancer (LARC) patients. The aim of this research is to investigate a correlation between the variation of radiomics features using pre- and post-neoadjuvant chemoradiation (nCRT) magnetic resonance imaging (MRI) with 2 years distant metastasis (2yDM) rate in LARC patients.Methods and MaterialsDiagnostic pre- and post- nCRT MRI of LARC patients, treated in a single institution from May 2008 to June 2015 with an adequate follow-up time, were retrospectively collected. Gross tumor volumes (GTV) were contoured by an abdominal radiologist and blindly reviewed by a radiation oncologist expert in rectal cancer. The dataset was firstly randomly split into 90% training data, for features selection, and 10% testing data, for the validation. The final set of features after the selection was used to train 15 different classifiers using accuracy as target metric. The models’ performance was then assessed on the testing data and the best performing classifier was then selected, maximising the confusion matrix balanced accuracy (BA).ResultsData regarding 213 LARC patients (36% female, 64% male) were collected. Overall 2yDM was 17%. A total of 2,606 features extracted from the pre- and post- nCRT GTV were tested and 4 features were selected after features selection process. Among the 15 tested classifiers, logistic regression proved to be the best performing one with a testing set BA, sensitivity and specificity of 78.5%, 71.4% and 85.7%, respectively.ConclusionsThis study supports a possible role of delta radiomics in predicting following occurrence of distant metastasis. Further studies including a consistent external validation are needed to confirm these results and allows to translate radiomics model in clinical practice. Future integration with clinical and molecular data will be mandatory to fully personalized treatment and follow-up approaches.

scholarly journals Phase II study of capecitabine plus oxaliplatin (CapOX) as adjuvant chemotherapy for locally advanced rectal cancer (CORONA II)

2019 ◽  
Vol 25 (1) ◽  
pp. 118-125 ◽  
Author(s):  
Norifumi Hattori ◽  
Goro Nakayama ◽  
Keisuke Uehara ◽  
Toshisada Aiba ◽  
Kiyoshi Ishigure ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Treatment Compliance ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Stage Ii ◽  
R0 Resection

Abstract Objective This multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer. Methods Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CapOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1–14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety. Results A total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CapOX therapy. The completion rate of all eight cycles of CapOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57–86%) and 96% (95% CI 80–99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively. Conclusion CapOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.

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