Nomogram including pretherapeutic parameters for prediction of early response after neoadjuvant treatment in rectal cancer: Results from a prospective randomized study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 716-716
Author(s):  
Jianwei Zhang ◽  
Yue Cai ◽  
Huabin Hu ◽  
Ping Lan ◽  
Lei Wang ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Randomized Study ◽  
External Validation ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Predictive Performance ◽  
Complete Response ◽  
Early Response ◽  
Preoperative Treatment ◽  
Internal Validation

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]

Preoperative treatment for marginally resectable metastatic melanoma: A single center experience in China.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22096-e22096
Author(s):  
Yu Xu ◽  
Xuxia Shen ◽  
Wei Sun ◽  
Yunyi Kong ◽  
Yong Chen ◽  
...  
Keyword(s):  
Positive Impact ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Complete Response ◽  
Braf V600e ◽  
Preoperative Treatment ◽  
Single Center Experience ◽  
A Prospective Study ◽  
The Impact

e22096 Background: Large randomized trials have proved that targeted therapy (TT) and immunotherapy (IT) can improve RFS for resectable Stage III melanoma. However, there is still a risk around 15%~25% of relapse within 1 year, especially worse for Stage IIID disease. Several neoadjuvant trials have shown a potentiality of long-term relapse-free after a pathologic complete response, especially for immunotherapy. We conducted a prospective study to investigate the impact of preoperative treatment on the anti-tumor efficacy and disease-free survival for Chinese melanoma. Methods: Stage IIID patients with matted nodes were recruited. For BRAF V600E-muted patients, Vemurafenib (V) was given for one months ahead of the surgery. For BRAF-wide-type patients, anti-PD1 antibody, Pembrolizumab(P) or Toripalimab (T) was given one dose per 3 weeks until response or intention-to-progression was observed. Pathologic assessment followed the principles for neoadjuvant therapy established by INMC. Results: Totally seven patients have been recruited. Detail information was listed in Table. Clinical ORR was 71%, however with no pCR observed. One patient in Vemurafenib group occurred brain mets within 1 month after surgery. All four patients in anti-PD1 group were relapse-free so far after median follow-up of 11 months. Conclusions: Preoperative BRAF targeted and anti-PD1 immunotherapy might guarantee a positive impact on anti-tumor response and local disease control for marginally resectable melanoma. However, the pathological criteria for neoadjuvant treatment might not be suitable to evaluate the matted or bulky specimen after preoperative treatment. [Table: see text]

Circulating Biomarkers for Response Prediction of Rectal Cancer to Neoadjuvant Chemoradiotherapy

2020 ◽  
Vol 27 (25) ◽  
pp. 4274-4294 ◽  
Author(s):  
Chiara Bedin ◽  
Sara Crotti ◽  
Edoardo D’Angelo ◽  
Sara D’Aronco ◽  
Salvatore Pucciarelli ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Clinical Benefit ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Neoadjuvant Chemoradiotherapy ◽  
Treatment Protocol ◽  
Predictive Biomarkers ◽  
Complete Response ◽  
Tumour Regression

: 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.

Organ preservation in patients with rectal cancer with clinical complete response after neoadjuvant therapy.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 509-509 ◽  
Author(s):  
Jesse Joshua Smith ◽  
Oliver S Chow ◽  
Anne Eaton ◽  
Maria Widmar ◽  
Garrett Michael Nash ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Neoadjuvant Therapy ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Oncologic Outcome ◽  
Complete Response ◽  
Rank Test ◽  
Salvage Operation ◽  
Clinical Complete Response ◽  
Kaplan Meier

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]

Predictors of Pathologic Complete Response After Neoadjuvant Treatment for Rectal Cancer: A Multicenter Study

2015 ◽  
Vol 14 (4) ◽  
pp. 291-295 ◽  
Author(s):  
Dawn Armstrong ◽  
Soundouss Raissouni ◽  
Julie Price Hiller ◽  
Jamison Mercer ◽  
Erin Powell ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Multicenter Study ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response

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 ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Response Rates ◽  
Complete Response ◽  
National Cancer Database

scholarly journals Total neoadjuvant treatment of locally advanced rectal cancer with high risk factors in Slovenia

2019 ◽  
Vol 53 (4) ◽  
pp. 465-472
Author(s):  
Mojca Tuta ◽  
Nina Boc ◽  
Erik Brecelj ◽  
Mirko Omejc ◽  
Franc Anderluh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Rectal Cancer ◽  
High Risk ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Distant Recurrence ◽  
High Risk Factors ◽  
Grade 3

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.

INNOVA: Interval or neoadjuvant chemotherapy in rectal cancer—A phase II randomized study comparing interval versus neoadjuvant chemotherapy in magnetic resonance imaging-defined high-risk rectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 91-91
Author(s):  
Ramakrishnan Ayloor Seshadri ◽  
Trivadi S. Ganesan ◽  
Manikandan Dhanushkodi ◽  
Arunkumar M N ◽  
Shirley Sundersingh
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Randomized Study ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Phase Iii ◽  
Clinical Trial Registry ◽  
Grade 3

91 Background: Total neoadjuvant treatment is a promising option in rectal cancer. We aim to compare neoadjuvant versus interval chemotherapy in high risk rectal cancer to identify the optimal sequencing of treatment. Methods: Using a Simon two-stage design, newly diagnosed MRI defined high risk rectal cancer patients were randomly assigned in a 1:1 ratio to receive three 21 day cycles of chemotherapy with Capecitabine 1000 mg/m2 and Oxaliplatin 130 mg/m2 either before (Arm A-neoadjuvant) or after (Arm B-interval) chemoradiation followed by surgery. Primary end point was the pathological complete response (pCR) following surgery. A heirarchial model was used to assess the primary and secondary end points (toxicity and compliance) and compare the two regimens. (Clinical Trial Registry of India No. CTRI/2015/01/005385). Results: In this single centre study conducted between November 2015 and February 2020, 42 patients were randomised in the first stage. A pCR was seen in 4 patients in Arm A and 6 in Arm B. Hence another 52 patients were randomised in the second stage of which an additional 3 and 2 patients had a pCR leading to an overall pCR of 7 and 8 patients (15.5% vs 17% and 18.4% vs 19.5% in the intent-to-treat and per-protocol populations in Arm A and B respectively. This exceeded the minimum predetermined number of 5 pCR needed to qualify for further evaluation for each arm. Grade ≥3 toxicity was observed in 2.2% of 132 cycles and 4.6% of 129 cycles of chemotherapy delivered in 45 and 43 patients in Arm A and B respectively while 11/43 (25.5%) and 10/47 (21.2%) patients experienced grade ≥3 toxicity during chemoradiation. Treatment break of > 7 days was seen in 23.2% and 29.7% of patients in Arm A and B respectively while 93.3% in Arm A and 100% of patients in Arm B completed all 3 planned cycles of pre-operative chemotherapy. A non-significant trend towards greater pathological downstaging was seen in Arm B than in Arm A (ypT1-2 39% vs 26.3%; p = 0.1 and ypN0 68.3% vs 57.9%; p = 0.5 respectively). Conclusions: In this phase two study, both neoadjuvant and interval chemotherapy emerged eligible for further evaluation against the standard of care in a future phase III study. Although we could not pick one winner based on pCR, toxicity or compliance, the greater downstaging observed with interval chemotherapy suggests it could play a greater role in an organ preservation approach. Clinical trial information:CTRI/2015/01/005385, UTN no: U111111650578.

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