Total Neo-adjuvant Therapy [TNT] with Short Course Radiotherapy [SCRT] Followed by Total Mesorectal Excision [TME]–Sandwich Protocol in Locally Advanced Rectal Cancer [LARC]: a Prospective Observational Study in an Indian Population
摘要
Recently, TNT comprising CRT with complete chemotherapy before surgery is being widely practiced to improve treatment outcomes especially distant failure rates. Although TNT is beneficial in treatment of LARC, there are few unanswered questions like optimal treatment strategy, type of chemotherapy regimen, radiotherapy regimen, and interval b/w RT and surgery that needs further research. This study describes the outcome of < < sandwich protocol > > TNT in patients with high risk LARC. A prospective non-comparative study was done, to evaluate treatment response, safety, and tolerance to TNT in LARC patients. TNT with sandwich protocol included 2 months NACT > > SCRT (25 Gy in 5#) > > 1 month NACT > > 8–10 weeks interval > > TME. Fifty patients with biopsy proven LARC were screened, 35 were included based on eligibility criteria, 31 completed TNT, and 29 underwent TME following TNT. All patients (100%) had R0 resection, CRM -ve with excellent quality of mesorectal resection. 10 patients had pCR (34.4%). pCR was observed more in patients receiving FOLFOXIRI regimen. No patients had de-escalation/withdrawal of treatment due to toxicity. Three patients died during study period, two of them due to comorbid illness, 1 due to disease progression. Although TNT with SCRT is considered more toxic, with less tolerability and compliance, along with concerns regarding increased local recurrence rate. TNT with Sandwich protocol was tolerated well, with excellent compliance and pathological response, acceptable toxicity & post-operative complications; however, more studies with Sandwich protocol with long-term outcomes can help to understand its clinical utility.