Pathologic Complete Response Rates After Neoadjuvant Treatment in Rectal Cancer: An Analysis of the National Cancer Database

2017 ◽  
Vol 24 (8) ◽  
pp. 2095-2103 ◽  
Author(s):  
Patrick D. Lorimer ◽  
Benjamin M. Motz ◽  
Russell C. Kirks ◽  
Danielle M. Boselli ◽  
Kendall K. Walsh ◽  
...  
2021 ◽  
pp. 790-796
Author(s):  
Muhammad Atif Mansha ◽  
Asmara Waheed ◽  
Tabinda Sadaf ◽  
Asma Rashid ◽  
Nabia Irfan ◽  
...  

PURPOSE To report the toxicity and pathologic response rates after adding neoadjuvant capecitabine and oxaliplatin (CAPOX) followed by concurrent radiation and capecitabine (CAPRT) and surgery in patients with locally advanced rectal cancer. MATERIALS AND METHODS We retrospectively analyzed medical records of 301 patients between January 2007 and December 2014. Patients were treated with four cycles of neoadjuvant chemotherapy comprising CAPOX, followed by radiotherapy at doses of 45-54 Gy in 25-30 fractions with concurrent capecitabine. A response assessment scan was performed at 4-6 weeks postradiation followed by surgical evaluation at 6-8 weeks. Pathologic tumor and nodal response rates as well as circumferential resection margin were assessed on surgical specimens. RESULTS The median age of the patients was 43 years (range, 16-78). Overall, 227 (75.4%) patients were able to complete four cycles of CAPOX. Neoadjuvant chemotherapy was well-tolerated with no serious adverse effects. The most common toxicity was diarrhea (grade 2, n = 108; 35.8%; grade 3, n = 57; 18.9%; grade 4, n = 25; 8.3%) followed by neuropathy (grade 2, n = 132; 43.8%; grade 3, n = 54; 17.9%) and oral mucositis (grade 2, n = 108; 35.8%; grade 3, n = 47; 15.6%; grade 4, n = 9; 2.99%). A total of 229 (76.1%) patients underwent surgery. Pathologic complete response was seen in 52 (22.7%; 95% CI, 13 to 28), whereas 200 (87.3%; 95% CI, 82 to 99) patients had a negative circumferential resection margin on pathology. CONCLUSION Neoadjuvant chemotherapy with CAPOX before CAPRT and planned total mesorectal excision surgery result in good tumor regression and substantial pathologic complete response rates with acceptable toxicity. With growing interest in organ preservation in rectal cancer, the strategy of completing all chemotherapy and chemoradiotherapy before planned surgery offers a favorable paradigm. However, further randomized clinical trials are needed to support this evidence.


2020 ◽  
Vol 27 (25) ◽  
pp. 4274-4294 ◽  
Author(s):  
Chiara Bedin ◽  
Sara Crotti ◽  
Edoardo D’Angelo ◽  
Sara D’Aronco ◽  
Salvatore Pucciarelli ◽  
...  

: Rectal cancer response to neoadjuvant Chemoradiotherapy (pCRT) is highly variable. In fact, it has been estimated that only about 21 % of patients show pathologic Complete Response (pCR) after therapy, while in most of the patients a partial or incomplete tumour regression is observed. Consequently, patients with a priori chemoradioresistant tumour should not receive the treatment, which is associated with substantial adverse effects and does not guarantee any clinical benefit. For Locally Advanced Rectal Cancer Patients (LARC), a standardized neoadjuvant treatment protocol is applied, the identification and the usefulness of prognostic or predictive biomarkers can improve the antitumoural treatment strategy, modifying the sequence, dose, and combination of radiotherapy, chemotherapy and surgical resection. : For these reasons, a growing number of studies are actually focussed on the discovery and investigation of new predictive biomarkers of response to pCRT. In this review, we have selected the most recent literature (2012-2017) regarding the employment of blood-based biomarkers potentially predicting pCR in LARC patients and we have critically discussed them to highlight their real clinical benefit and the current limitations of the proposed methodological approaches.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 509-509 ◽  
Author(s):  
Jesse Joshua Smith ◽  
Oliver S Chow ◽  
Anne Eaton ◽  
Maria Widmar ◽  
Garrett Michael Nash ◽  
...  

509 Background: Nonoperative management (NOM) of rectal cancer following a clinical complete response (cCR) to neoadjuvant therapy is a non-standard approach. We review our experience with NOM to evaluate safety and efficacy. Methods: A retrospective review of prospectively collected data between 2006 and 2014 was conducted. We compared patients completing neoadjuvant therapy for stage I to III rectal cancers who: a) achieved cCR and were treated with NOM, or b) underwent standard total mesorectal excision (TME) and achieved a pathologic complete response (pCR). Kaplan-Meier estimates and the log-rank test were used. Results: Seventy-three patients underwent NOM after cCR. From 369 rectal resections performed, 72 (20%) achieved pCR and form the comparison group. Median follow-up across both groups was 3.3 years. Rectal preservation was achieved in 56 (77%) of the patients treated with NOM. Of the 19 NOM patients with local regrowth, 18 were salvaged successfully with standard TME (n=16) or local excision (n=2), with one patient pending a salvage operation (n=1). No significant differences were noted in the number of distant recurrences between the NOM and pCR groups. Four-year disease-specific survival and overall survival between the two groups were not significantly different. Conclusions: In this highly selected group of patients with cCR to neoadjuvant treatment, NOM with surgical salvage of local tumor regrowth achieved local control in all patients. The oncologic outcome for NOM patients at 4 years was comparable to patients with pCR after rectal resection. These data continue to suggest that NOM does not compromise oncologic outcome, and that preservation of the rectum is achieved in a majority of patients. [Table: see text]


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 716-716
Author(s):  
Jianwei Zhang ◽  
Yue Cai ◽  
Huabin Hu ◽  
Ping Lan ◽  
Lei Wang ◽  
...  

716 Background: To establish a clinical nomogram with pretherapeutic parameters for predicting pathologic complete response (pCR) and tumor downstaging after neoadjuvant treatment in patients with rectal cancer. Methods: From Jan 2011 to Feb 2015, complete data was available for 309 patients with rectal cancer who received concurrent chemoradiotherapy or chemotherapy alone enrolled in FOWARC study. All pre-treatment clinical parameters were collected to build a nomogram for pCR and tumor down-staging. The model was subjected to bootstrap internal validation. The predictive performance of the model was assessed with concordance index (c-index) and calibration. Results: Of the 309 patients, 55 (17.8%) had achieved pCR, 138 (44.7%) patients were classified as good down-staging with ypTNM stage 0-I. Basing on the multivariate logistic regression and clinical consideration, 5 factors were identified to be the independent predictors for pCR and good downstaging, respectively (Table 1). The predictive nomograms were developed (fig 1 and 2) to predict the probability of pCR and good down-staging with a C-index of 0.802 (95% CI: 0.736-0.867) and 0.73 (95% CI: 0.672-0.784). Calibration plots showed good performance on internal validation. Conclusions: The nomograms provide individual prediction of response to different preoperative treatment for patients with rectal cancer. This model may help physician in patient selection for optimized treatment. Further external validation is warranted. [Table: see text]


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 616-616 ◽  
Author(s):  
Shaakir Hasan ◽  
Paul Renz ◽  
Rodney E Wegner ◽  
Gene Grant Finley ◽  
Moses S. Raj ◽  
...  

616 Background: The relationship between microsatellite instability (MSI) and response to neoadjuvant chemoradiation in rectal cancer is not well understood. We therefore utilized the national cancer database (NCDB) to investigate the association between MSI and pathologic complete response (pCR) in this patient population. Methods: We analyzed 5,086 patients between 2010-2015 with locally advanced rectal cancer who were tested for MSI and treated definitively with chemoradiation followed by surgery. Primary comparison groups were between 4,450 MSI-negative(-) and 636 MSI-positive(+) patients. Multivariable regression analysis was conducted to identify demographic, therapeutic, and clinical characteristics predictive of pCR. Cox proportional hazard ratios were used for survival. Results: All patients were treated with definitive chemoradiation (median dose 50.4 Gy) followed by resection within 4 months. MSI(+) patients were associated with earlier year of diagnosis and higher grade tumors (P < 0.05). The overall pCR rate was 8.6%, including 8.9% for MSI(-) and 5.9% for MSI(+) tumors (P = 0.01). Along with lower T stage, MSI(+) cases were significantly associated with a reduced pCR rate (OR = 0.65, 95% CI 0.43 – 0.96) with multivariable analysis. The 5-year survival for patients with pCR was 93% compared to 73% without it (< 0.001). Conclusions: Microsatellite instability was independently associated with a reduction in pathologic complete response for locally advanced rectal cancer following neoadjuvant chemoradiation in this NCDB-based analysis.[Table: see text]


2015 ◽  
Vol 14 (4) ◽  
pp. 291-295 ◽  
Author(s):  
Dawn Armstrong ◽  
Soundouss Raissouni ◽  
Julie Price Hiller ◽  
Jamison Mercer ◽  
Erin Powell ◽  
...  

2019 ◽  
Vol 53 (4) ◽  
pp. 465-472
Author(s):  
Mojca Tuta ◽  
Nina Boc ◽  
Erik Brecelj ◽  
Mirko Omejc ◽  
Franc Anderluh ◽  
...  

Abstract Background In the light of a high rate of distant recurrence and poor compliance of adjuvant chemotherapy in high risk rectal cancer patients the total neoadjuvant treatment was logical approach to gaining acceptance. We aimed to evaluate toxicity and efficiency of this treatment in patients with rectal cancer and high risk factors for local or distant recurrence. Patients and methods Patients with rectal cancer stage II and III and with at least one high risk factor: T4, presence of extramural vein invasion (EMVI), positive extramesorectal lymph nodes or mesorectal fascia (MRF) involvement were treated with four cycles of induction CAPOX/FOLFOX, followed by capecitabine-based radiochemotherapy (CRT) and two consolidation cycles of CAPOX/FOLFOX before the operation. Surgery was scheduled 8–10 weeks after completition of CRT. Results From November 2016 to July 2018 66 patients were evaluable. All patients had stage III disease, 24 (36.4%) had T4 tumors, in 46 (69.7%) EMVI was present and in 47 (71.2%) MRF was involved. After induction chemotherapy, which was completed by 61 (92.4%) of patients, radiologic downstaging of T, N, stage, absence of EMVI or MRF involvement was observed in 42.4%, 62.1%, 36.4%, 69.7% and 68.2%, respectively. All patients completed radiation and 54 (81.8%) patients received both cycles of consolidation chemotherapy. Grade 3 adverse events of neoadjuvant treatment was observed in 4 (6%) patients. Five patients rejected surgery, 3 of them with radiologic complete clinical remissions. One patient did not have definitive surgery of primary tumor due to unexpected cardiac arrest few days after sigmoid colostomy formation. Among 60 operated patients pathological complete response rate was 23.3%, the rate of near complete response was 20% and in 96.7% radical resection was achieved. Pathological T, N and stage downstaging was 65%, 96.7% and 83.4%, respectively. Grade ≥ 3 perioperative complications were anastomotic leakage in 3, pelvic abscess in 1 and paralytic ileus in 2 patients. The rate of pathologic complete response (pCR) in patients irradiated with 3D conformal technique was 12.1% while with IMRT and VMAT it was 37% (p < 0.05). Hypofractionation with larger dose per fraction and simultaneous integrated boost used in the latest two was the only factor associated with pCR. ConclusionsTotal neoadjuvant treatment of high risk rectal cancer is well tolerated and highly effective with excellent tumor and node regression rate and with low toxicity rate. Longer follow up will show if this strategy will improve distant disease control and survival.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22159-e22159
Author(s):  
J. A. García-Sáenz ◽  
M. Martín ◽  
M. Maestro ◽  
M. Vidaurreta ◽  
S. Veganzones ◽  
...  

e22159 Background: A prospective study was conducted to determine the value of changes in circulating tumor cell (CTC) levels prior to and after the first cycle of neoadjuvant treatment in early prediction of pathologic response in locally advanced breast cancer (LABC). Methods: Two blood samples were obtained from 72 eligible LABC patients to isolate and enumerate CTCs before neoadjuvant chemotherapy started on day 1, and on day 21, immediately before second cycle administration. Results: Sixty patients (83.3%) had ≤1 CTC in the first sample and response rates in this cohort were: pathologic complete response (PCR) in 2 patients (5%); partial response (PR) in 35 (87.5%); stable disease (SD) in 2 (5%); progressive disease (PR) in 1 (2.5%). Twelve patients (16.7%) had ≥2 CTCs in the first sample; these patients were more likely to have triple negative tumors. All 12 had fewer CTCs in the second sample. Response rates in this second cohort of 12 patients were: PCR in 4 (34%); PR, 6 (50%); SD, 1 (8%); and PD, 1 (8%). pCR rate was markedly better in this second cohort (p<0.0042; OR 14.5, 95% CI 2.3–92). Conclusions: This study suggests that the presence of CTCs prior to neoadjuvant therapy might be a predictor of response to this therapy. No significant financial relationships to disclose.


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