VOLTAGE-B study: Nivolumab monotherapy and subsequent curative surgery following preoperative chemoradiotherapy in patients with locally recurrent rectal cancer (LRRC) without previous radiotherapy.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 100-100
Author(s):  
Takeshi Kato ◽  
Hideaki Bando ◽  
Yuichiro Tsukada ◽  
Koji Inamori ◽  
Mamoru Uemura ◽  
...  

100 Background: Chemoradiotherapy (CRT) followed by curative resection in patients (pts) with local recurrence after radical surgery for primary rectal cancer is the preferred strategy if radiotherapy (RT) was not previously performed. In VOLTAGE-A study, nivolumab plus surgery following CRT showed a promising pathologic complete response (pCR) rate of 30% in pts with microsatellite-stable (MSS) advanced primary rectal cancer. The treatment sequence was prospectively investigated in pts with Locally Recurrent Rectal Cancer (LRRC) in VOLTAGE-B. Methods: Pts with pelvic LRRC without previous RT were included. Five cycles of nivolumab (240 mg q2 weeks) plus curative surgery following CRT (50.4 Gy with capecitabine 1,650 mg/m2) were performed. The pCR rate using AJCC tumor regression grading and curative resection rate were key endpoints. Planned sample size in VOLTAGE-B was set 10 pts in an exploratory manner. Results: From May to Oct 2018, 10 pts were included. Median age was 65 and 8 were male. Curative resection was performed in nine pts with MSS. One had a newly diagnosed supraclavicular lymph node metastasis before surgery. As one pt with AJCC grade 0, seven with grade 2, and one with grade 3, were observed, pCR rate was 10%. As of cut-off date of Apr 2019, three pts showing recurrence out of the nine pts were observed. Nivolumab-related adverse events (AEs) were only one pt with grade 1 hyperthyroidism and one with grade 1 erythema. Grade 3/4 surgery-related AEs were observed in six pts, including two pts with ileus and two with pelvic infections. No treatment-related deaths were observed. Conclusions: The pCR rate of 10% with acceptable toxicity was shown in MSS LRRC pts treated with nivolumab plus curative surgery following CRT. Translational research exploring better predictors of efficacies of study treatment are ongoing. Clinical trial information: NCT02948348.

2021 ◽  
Author(s):  
JUNICHI SAKAMOTO ◽  
Heita Ozawa ◽  
Hiroki Nakanishi ◽  
Shin Fujita

Introduction: Given that doubling time is an indicator of tumor growth, we assessed the usefulness of carcinoembryonic antigen doubling time (CEA-DT) in prognosis prediction after curative resection for locally recurrent rectal cancer. Methods: During January 1986 to December 2016, 33 patients with locally recurrent rectal cancer who underwent curative resection at our hospital were retrospectively reviewed. The primary endpoint was the 3-year recurrence-free survival (RFS) rate. The Kaplan-Meier method was used to compare RFS rates and evaluate univariate and multivariate analyses for factors associated with oncologic outcomes, including CEA-DT. CEA-DT was classified into two groups: the short and long CEA-DT groups. Results: The 3-year overall survival and RFS rates were 62.6% and 42.4%, respectively. In multivariate analyses, CEA-DT was an independent risk factor for poor RFS. The 3-year RFS rate was significantly better in the long CEA-DT group than in the short CEA-DT group (58.8% vs. 25.0%, p = 0.0063). Conclusion: CEA-DT is a useful prognostic factor that can be assessed before surgery for locally recurrent rectal cancer. Long CEA-DT may indicate a favorable prognosis. Contrarily, short CEA-DT is associated with poor prognosis; therefore, further treatment intervention is necessary for patients with short CEA-DT.


2004 ◽  
Vol 11 (S2) ◽  
pp. S108-S108
Author(s):  
I. Bedrosian ◽  
G. Giacco ◽  
L. Pederson ◽  
M. Rodriguez-Bigas ◽  
B. Feig ◽  
...  

2020 ◽  
Author(s):  
Xin Cai ◽  
Yueyao Du ◽  
Zheng Wang ◽  
Ping Li ◽  
Zhan Yu ◽  
...  

Abstract Background Treatment for locally recurrent rectal cancer after surgery is still a challenge. With the physical and biological advantages, carbon-ion radiotherapy (CIRT) could be a choice for these patients. The purpose of this study was to investigate the efficacy and safety of CIRT for unresectable locally recurrent rectal cancer in Chinese patients. Methods Date from 25 patients with unresectable locally recurrent rectal cancer treated by CIRT from July 2015 to April 2019 were analyzed retrospectively. The endpoints of this study were overall survival (OS), local control (LC) and acute and late toxicity. Results With the median follow-up of 19.6 (range 5.1–52.5) months, data of all 25 patients were collected. Median prescribed dose for tumor was 72 Gy (relative biologic efficacy (RBE)) (range 48-75.6 Gy (RBE)). The LC rates at 1 and 2 years were 90.4% and 71.8%. Overall LC at 1- and 2-year were 76.2% and 30.5% for 9 patients whose prescribed tumor doses of CIRT < 66 Gy (RBE), 100% and 100% for 16 patients whose prescribed doses of CIRT ≥ 66 Gy (RBE). Patients received ≥ 66 Gy (RBE) had obviously better LC rates than those received < 66 Gy (RBE) (P = 0.001). The OS rates at 1 and 2 years were 82.9% and 65.1%, respectively. No acute toxicity over grade 2 was observed, grade 3 late toxicity were observed in 3 patients: gastrointestinal toxicity (n = 1), neuropathy (n = 1), pelvic infection (n = 1). No Grade 4 or higher toxicity was observed. Conclusion Our study shows that CIRT is effective for unresectable locally recurrent rectal cancer patients with acceptable toxicity.


2004 ◽  
Vol 8 (S1) ◽  
pp. s132-s134 ◽  
Author(s):  
E. Christoforidis ◽  
I. Kanellos ◽  
T. Tsachalis ◽  
K. Blouhos ◽  
I. Lamprou ◽  
...  

2006 ◽  
Vol 49 (2) ◽  
pp. 175-182 ◽  
Author(s):  
Isabelle Bedrosian ◽  
Geoffrey Giacco ◽  
Lee Pederson ◽  
Miguel A. Rodriguez-Bigas ◽  
Barry Feig ◽  
...  

2011 ◽  
Vol 77 (8) ◽  
pp. 1086-1090 ◽  
Author(s):  
Omar H. Llaguna ◽  
Benjamin F. Calvo ◽  
Karyn B. Stitzenberg ◽  
Allison M. Deal ◽  
Charles T. Burke ◽  
...  

The surgical management of locally advanced primary rectal cancer and locally recurrent rectal cancer requires complex operations frequently resulting in complicated postoperative courses. We sought to evaluate the utilization of interventional radiologic (IR) procedures in the management of postoperative complications. Under Institutional Review Board approval, a prospective database of colorectal cancer patients undergoing resection from July 1999 to January 2010 was analyzed. Data collected included demographics, operative procedure, complications, length of stay, and IR utilization. Fisher's exact tests and logistic regression explored associations with necessitating an IR procedure during the postoperative period. Continuous variables were analyzed using Wilcoxon rank sum tests. One hundred and one patients underwent surgery and 66 received intraoperative electron radiotherapy (IOERT). Primary procedures included pelvic exenteration (n = 35), abdominoperineal resection (n = 25), low anterior resection (n = 23), paraaortic node dissection (n = 7), resection of isolated pelvic/retroperitoneal tumor (n = 7), and colectomy (n = 4). Sixty-two patients required multivisceral resection including partial/total cystectomy (n = 30), small bowel resection (n = 25), oophorectomy (n = 15), vaginectomy (n = 12), hysterectomy (n = 12), hepatectomy (n = 3), and nephrectomy (n = 3). Seventeen partial sacral resections and 47 pelvic sidewall resections were also required. One hundred and thirty-eight complications were identified in 72 patients, 30 of which required a procedural intervention. Twenty-seven IR procedures were performed including drainage of fluid collections (n = 14), nephrostomy tube placement (n = 8), arterial embolization (n = 2), inferior vena cava filter placement (n = 2), and pleural drainage (n = 1). Only three reoperations were required, none related to failure of IR procedures. There were no deaths. Estimated blood loss > 2000 mL ( P = 0.002), IOERT ( P = 0.03), and incomplete resection ( P = 0.02) were found to be associated with postoperative IR utilization. Surgery for locally advanced primary rectal cancer and locally recurrent rectal cancer is associated with significant morbidity but low mortality. IR procedures play a significant role in the postoperative management of these patients and may decrease the need for reoperation.


Sign in / Sign up

Export Citation Format

Share Document