Systematic Review of FDG-PET Prediction of Complete Pathological Response and Survival in Rectal Cancer

The aim of this study was to evaluate the safety and clinical efficacy of a combined preoperative regimen consisting of volumetric modulated arc therapy–simultaneous integrated boost and capecitabine chemotherapy for distal rectal cancer. A total of 26 patients with locally advanced distal rectal cancer were enrolled from March 2015 to May 2016. The radiation dose fractionation was 58.75 Gy/25 fractions (2.35 Gy/fraction) for rectal tumor and pelvic lymph node metastasis and 50 Gy/25 fractions for pelvic lymph node stations, accompanied with simultaneous capecitabine chemotherapy. Completion of the simultaneous chemotherapy was ensued by 1 week of rest and then another cycle of induction chemotherapy with capecitabine. A radical rectal cancer surgery was performed 6 to 8 weeks after the simultaneous chemoradiotherapy. The primary end points were the complete pathological response rate and the postoperative sphincter preservation rate. All 26 patients completed the neoadjuvant chemoradiotherapy, among which 25 received surgical treatment. The postoperative complete pathological response rate was as high as 32% (8/25), while the sphincter preservation rate was 60% (15/25), the overall tumor/node (T/N) downstaging rate was 92% (23/25), and the R0 resection rate was 100%. During the chemoradiation, the most common adverse events were grade 1 and 2; grade 3 radiodermatitis occurred in 2 cases but no occurrence of acute adverse events occurred that were grade 4 and above. After the surgery, there was one case of ureteral injury and one case of intestinal obstruction, but no perioperative deaths occurred. In conclusion, the chemoradiation regimen of preoperative volumetric modulated arc therapy-simultaneous integrated boost (VMAT-SIB58.75Gy) and a single cycle of induction chemotherapy with capecitabine for patients with distal rectal cancer is safe and feasible with a satisfactory complete pathological response rate, sphincter preservation rate, and R0 resection rate.

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A specific miRNA signature correlates with complete pathological response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.3610 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. 3610-3610

Author(s):

G. Della Vittoria Scarpati ◽

C. Carlomagno ◽

S. Marchini ◽

P. Ubezio ◽

F. Falcetta ◽

...

Keyword(s):

Rectal Cancer ◽

Locally Advanced ◽

Neoadjuvant Chemoradiotherapy ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer ◽

Pathological Response ◽

Mirna Signature ◽

Complete Pathological Response

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The effect of MRI or PET fusion in radiotherapy treatment planning on the pathological complete response rate in rectal adenocarcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.523 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 523-523

Author(s):

Zaker Hamid Rana ◽

Robert Hong ◽

Joon Han ◽

Isaac Chen ◽

Mohammed Nurhussien ◽

...

Keyword(s):

Rectal Cancer ◽

Treatment Planning ◽

Response Rate ◽

Pathological Complete Response ◽

Complete Response Rate ◽

Rectal Adenocarcinoma ◽

Complete Response ◽

Preoperative Chemoradiation ◽

Pathological Response ◽

Complete Pathological Response

523 Background: A pathological complete response rate of 10% to 30% has been noted to occur following preoperative chemoradiation with CT-based treatment planning in patients with rectal cancer. Fusion of the treatment planning CT with other imaging modalities like MRI or PET may help identify tumor location and improve tumor coverage. This retrospective study sought to evaluate the effect of adding MRI or PET imaging to CT-based treatment planning and its impact on pathological complete response rates in patients with rectal cancer. Methods: A retrospective analysis was performed on 39 patients, who received neoadjuvant chemoradiation for rectal adenocarcinoma from February 2009 to September 2013. Patients were divided into two groups. The first group was treated using CT-only based treatment 3D-Conformal or IMRT planning (n=9) and the second was treated using either PET or MRI fusion with the simulation CT scan (n=30). Patients were treated to a total of 5,040 cGy in 28 fractions. Pathological complete response rates (ypT0N0M0) were assessed using postoperative pathologic reports following resection. Results: 39 patients with a median age of 62 received preoperative chemoradiation with an interval to surgery ranging from 34-162 days and a median of 70 days. Patients treated with PET or MRI fusion treatment planning showed a complete pathological response rate at the primary site of 60% and a complete lymph node pathological response rate of 70.83% compared to 22.22% at the primary site and 66.66% at lymph node sites in patients with CT-only treatment planning. In patients treated using MRI or PET fusion, middle rectal cancer showed the best complete pathological response rate at 80%, followed by lower rectal cancer at 41.66%, and upper rectal cancer at 37.5%. Conclusions: Although the sample size was small, utilization of MRI or PET fusion resulted in a higher pathological complete response rate when compared to CT-only based treatment planning, especially in middle rectal cancers. Further studies are needed to accurately identify those patients with a complete pathologic response which may ultimately alter their treatment course.

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Phase II trial PD-L1/PD-1 blockade avelumab with chemoradiotherapy for locally advanced resectable T3B-4/N1-2 rectal cancer: The Ave-Rec trial.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.tps3622 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. TPS3622-TPS3622

Author(s):

Michael Michael ◽

Rachel Wong ◽

Sanjeev Singh Gill ◽

David Goldstein ◽

Sam Ngan ◽

...

Keyword(s):

Rectal Cancer ◽

Sample Size ◽

Phase Ii ◽

Fdg Pet ◽

Immune Cell ◽

Response Rate ◽

Locally Advanced ◽

Pathological Response ◽

Pelvic Mri ◽

Distant Relapse

TPS3622 Background: Standard neoadjuvant long course chemoradiotherapy (LCCRT) for locally advanced rectal cancer (LARC) results in a complete pathological response rate of 10-30%: but 20-40% of patients (pts) are non-responders, 10-15% have local recurrence. Tumoural immune infiltrates are predictive of response. Preclinical studies show that radiotherapy (RT) via interferon signaling is immuno-stimulatory, enhancing local/distant tumour cell death. RT also stimulates PDL1 production and the immunosuppressive activity of myeloid derived suppressor cells. Hence PDL1 inhibition may be required to enhance the immuno-stimulatory effects of RT. Hypothesis: In pts with resectable LARC, the anti-PDL1 antibody Avelumab post LCCRT may enhance the pathological/imaging response rates whilst potentially reducing local/distant relapse rates. Methods: (1) Trial Design: Phase II single arm trial, across 6 Australian sites (2) Endpoints: (a) Primary; Pathological response rate post-LCCRT, as documented by central pathologist, (b) Secondary; MRI/FDG PET imaging responses at 8 weeks post LCCRT (pre-surgery). Toxicity. (c) Exploratory; Tumoural immune cell subsets/checkpoint expression (by multiplex immunohistochemistry and in-vitro functional assays) and ctDNA analysis at baseline and during treatment. Distant relapse-free survival and the documentation of sites of relapse. (3) Sample size: An increase in the proportion of pathological complete responses by > 25% (from 10% to 35%) will be considered clinically important. Power = 90%, α = 0.05, 41 pts are required– an additional 4 pts to allow for drop-out. Total sample size = 45pts. Treatment: All pts to receive standard LCCRT (50.4Gy RT plus 5FU [225mg/m2/day/CI] or Capecitabine [825mg/m2 BID on RT days] over 5.5 weeks). Post LCCRT (prior to surgery), pts receive 4 cycles Avelumab (10mg/kg, q2 weeks). Surgical resection 10-12 weeks post LCCRT. Fresh tumour biopsy and ctDNA sampling pre LCCRT, pre Cycle 1 Avelumab and at surgery. Response by FDG PET and pelvic MRI pre surgery. Pts to be followed up for 2 years. Major Inclusion Criteria: Pts with LARC, MRI stage T3b-4/N1-2/M0, planned for LCCRT followed by curative resection, tumoural lower border within 12cm from the anal verge, measurable disease (RECIST1.1), ECOG 0-1, adequate organ function and no contraindications to Avelumab therapy. Current Enrolment: 11 of the planned 45 patients enrolled. Clinical trial information: NCT03299660.

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Outcomes of rectal cancer patients treated using Polish II neoadjuvant short course radiation therapy and chemotherapy approach in comprehensive cancer center.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e16088 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e16088-e16088

Author(s):

Stephen Haff ◽

Syed Mohammad Ali Kazmi ◽

Nina Niu Sanford ◽

Todd Anthony Aguilera ◽

Muhammad Shaalan Beg ◽

...

Keyword(s):

Rectal Cancer ◽

Cancer Patients ◽

Safety Net ◽

Pathological Response ◽

Stage I ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Complete Pathological Response ◽

Post Surgery ◽

Short Course

e16088 Background: Neoadjuvant short-course (SC) radiation (RT) followed by fluoropyrimidine based chemotherapy prior to surgery (Polish II approach) is a less utilized treatment in the United States for rectal cancer. Based on data suggesting equivalent or improved outcomes at lower cost compared to the long course neoadjuvant chemoradiation, our team started utilizing this approach for rectal cancer management at Simmons Comprehensive Cancer Center. We aim to document our experience with Polish II approach at NCI-designated comprehensive cancer center program. Methods: A retrospective review of stage I-IV rectal cancer patients, seen at an academic center or the Dallas County safety net hospital and treated at Simmons Comprehensive Cancer Center from Nov 2017 to Dec 2019. Patients were treated with neoadjuvant SC-RT followed by 3 cycles of FOLFOX prior to surgery and followed by adjuvant FOLFOX. Descriptive data for demographic, radiation, chemotherapy and surgery, hospitalizations, 30 day post-surgery admission, time to relapse, and laboratory parameters was collected. Results: Thirty-nine patients met the inclusion criteria (average age 58 years; 74% men/26% women). Forty-six percent of patients were Hispanic, 28.2% White, 15.4% African American and 7.7% Asian. The majority of patients had stage IIIB (46.2%), followed by IIIC (17.9%), IIA (12.8%), IIIA (7.7%), while rest were stage I, IVA or unknown (5.1%). All patients received 5 x 5 SC-RT, 100% completed 3 cycles of planned neoadjuvant FOLFOX (12.8% received 4-8 cycles) and 36/39 (92%) of patients underwent planned surgery. Median duration from SC-RT to chemotherapy was 12 days, and from chemotherapy to surgery was 37 days. Hospitalization occurred in 3 patients (7.7%) during neoadjuvant therapy, and in 8 patients (20.5%) within 30 days post-surgery. Complete pathological response was seen in 6 patients (16.6%) and near-complete pathological response in 3 patients (8.3%). Relapse occurred in 10.3% patients at time of data acquisition. Grade 3 and 4 neutropenia, anemia, and thrombocytopenia in neoadjuvant phase was observed in 8.6%, 25.7%, and 2.8% patients, respectively. Conclusions: In rectal cancer patients treated at a comprehensive cancer center, neoadjuvant Polish-II approach was feasible and well tolerated. Pathological response rates were comparable to historical data. SC-RT based neo-adjuvant therapy approach should be favored due to lower pelvic radiation dose, tolerance and convenience to patients.

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