PracticeUpdate: Haematology & Oncology

CONFERENCE COVERAGE 22

More patients with rectal cancer are candidates for a watch-and-wait approach R eal-world data from the large, observational International Watch and Wait Database Consortium suggests rectal surgery carries the risk of debilitating complications, such as colostomy and urinary and sexual problems.

presurgery treatment varies significantly, as well as approaches for determining whether a tumour regresses or disappears after chemoradiation and for monitoring for recurrence. After a median follow-up of 2.6 years, 25% of patients underwent delayed surgery for recurrence. Distant metastases had occurred in 7% (n=49) of patients. The 3-year survival rate was 91% among all patients, and 87% among those who experienced local cancer recurrence. This is consistent with historic data from patients who undergo surgery. Dr van der Valk said, “Despite the excellent outcomes in our study, the decision to undergo surgery is personal. Faced with the risk of permanent colostomy, some patients avoid surgery. Others opt not to deal with the uncertainty of potential recurrence.” The consortium continues to collect all available prospective and retrospective data on watch-and-wait strategies in rectal cancer. Further data collection and analysis may inform international guidelines on treatment and surveillance for patients with rectal cancer. Median relapse-free survival was 30.4 (95% CI 15.4–45.8) vs 22.0 months (95% CI 13.6–38.3) in arms A and B, respectively. After 4-years, relapse-free survival was 39.3% (95% CI 28.4% –50.0%) vs 33.2% (95% CI 23.1–43.7%). Global Health health-related quality of life scores did not differ at 12 (70.8 vs 83.3) or 24 months (75.0 vs 83.3). Dr Edeline said, “Adjuvant chemotherapy using GemOx for biliary tract cancer was feasible and associated with expected tox- icities and no deterioration of health-related quality of life.” He continued, “No significant difference in relapse-free survival was observed, how- ever, between GemOx and surveillance in patients with localised biliary tract can- cer. New trials are required to improve the results in localised biliary tract cancer. “Results of this first large phase III trial of a modern regimen in the adjuvant setting lead to the conclusion that adjuvant chemother- apy cannot be recommended in biliary tract cancer.” PracticeUpdate Editorial Team

that omitting surgery in strictly selected patients with a clinical complete response does not compromise outcomes. Maxime Van Der Valk, MD, of Leiden University Medical Center, The Netherlands, explained that rectal cancer treatment strategies vary widely across and within countries, but surgery is a standard component of care. In most countries, patients with stage 2–4 rectal cancer receive chemotherapy and/ or radiation before surgery. Though in about 20% of patients, the tumour disappears completely disappears after presurgery therapy, it is not standard to reassess or restage the tumour to determine whether surgery is still needed. The 3-year survival rate among patients who received watch-and-wait care after initial cancer treatment was 91%, similar to historic survival rates for patients who undergo surgery. This is welcome news, as surveillance in a multicentre, randomised phase 3 trial in patients with localised biliary tract cancer, reports outcome of PRODIGE 12-ACCORD 18. Julien Edeline, MD, of Eugene Marquis Comprehensive Cancer Center, Rennes, France, explained that no standard postsur- gery adjuvant treatment is recommended in localised biliary tract cancer. Gemcitabine combined with platinum is the standard chemotherapy for advanced biliary tract cancer. Dr Edeline and colleagues set out to deter- mine whether GemOx would improve relapse-free survival while maintaining health-related quality of life. “Despite the high risk of relapse,” he said, “there is no proven adjuvant therapy after surgery for bil- iary tract cancer.” Patients were randomised within 3 months of R0 or R1 resection of a localised biliary tract cancer (intrahepatic, perihilar, extra- hepatic cholangiocarcinoma or gallbladder cancer) to either GemOx 85 for 12 cycles

The International Watch and Wait Database includes 35 institutions in 11 countries. The database was established in 2014 and is the largest series of patients with rectal cancer for whom surgery was omitted after chemotherapy and radiation. The analysis included 802 patients with no signs of residual cancer after induction treatment, based on physical exam, endoscopy, or MRI or CT scans following chemotherapy and radiation. All patients received watch- and-wait care, which included intensive monitoring for cancer recurrence. In the first 2 years, patients visited the hospital every 3 months for endoscopy, MRI scans, and physical exams. Watch and wait is not yet a standard of care for patients with rectal cancer in any country, and is used in fewer than 5% of patients. No universal watch-and-wait strategy has been adopted for rectal cancer. Worldwide, Coprimary endpoints were relapse-free survival and health-related quality of life. A total of 190 patients and 126 relapse-free events were required to show an increase in median relapse-free survival from 18 to 30 months. Between 2009 and 2014, 196 patients were included in 33 French centres. Baseline characteristics were balanced, with similar primary sites. R0 resection rates were 86.2% (arm A) vs 87.9% (arm B). Lymph node invasion was present in 37.2% vs 36.4%, in arm A, a median of 12 (mean 9.3, range 0–12) cycles were delivered. Max- imal grade of adverse events was grade 3 in 57.5% vs 22.2%, and grade 4 in 17.0% vs 9.1%, respectively. One patient died in each arm. The main grade 7.0% vs 9.1% French centres. Median follow-up duration was 44.3 months, with 54 and 64 relapse-free sur- vival events in arm A vs B, respectively. No significant difference in relapse-free survival was observed between arms.

Adjuvant GemOx does not improve relapse-free survival in localised biliary tract cancer N o significant difference in relapse-free survival was observed between gem- citabine and oxaliplatin (GemOx) and (experimental armA) or surveillance (stand- ard arm B).

PracticeUpdate Editorial Team

PRACTICEUPDATE HAEMATOLOGY & ONCOLOGY