Deferred Surgery Feasible for Chemoradiation-Responsive Distal Rectal Cancer Patients

Deferred surgery investigated for T2/T3 distal rectal cancer patients who achieve a complete response to chemoradiotherapy

medwireNews: High-dose chemoradiation followed by watchful waiting may be an option for patients with stage T2 or T3 distal rectal cancer and no more than three positive lymph nodes (N0/N1), Danish clinicians suggest.

Local recurrence within a year of achieving a complete clinical response to chemoradiation was reported for 15.5% of the 40 patients who deferred surgery, and this was within the predefined “clinically acceptable” rate of 30% or below, the team reports in The Lancet Oncology.

After 2 years, the local recurrence rate was 25.9% and three patients had developed lung metastases requiring curative resection; the estimated overall tumour control rate was 58% at this timepoint.

“These patients all avoided major, potentially harmful surgery, with apparent excellent functional outcome”, write Ane Appelt, from Vejle Hospital, and co-authors.

The treatment regimen consisted of a 6-week course of weekday oral tegafur-uracil plus 60 Gy radiation in 30 fractions to the tumour, 50 Gy in 30 fractions to the lymph node volumes and a 5-Gy endorectal brachytherapy boost.

Of the 51 patients assigned to treatment, 98% received the full radiotherapy schedule and 84% full-dose chemotherapy. There were no grade 4 or 5 acute toxicity events and diarrhoea was the most common grade 3 event, affecting 8%.

The researchers report that 72% of 25 patients in the deferred surgery group reported good sphincter function at 1 year, as did 69% of 16 patients at 2 years, with no faecal incontinence. This was supported by the physician-reported Jorge-Wexner score of 0 at all timepoints, they add.

Late toxicity was reported in two patients with grade 3 rectal bleeding in the first year and one further patient within 2 years.

However, Anne Breugom and Cornelis van de Velde, from Leiden University Medical Centre in the Netherlands, note in an accompanying comment that chemoradiotherapy has previously been associated with serious late toxicity events and caution that “invalidating long-term toxicity” may yet occur in this patient group.

“The question remains of whether the benefits of intensive chemoradiotherapy followed by observation outweigh the possible long-term adverse effects—especially for patients with clinical T2 rectal cancer, who are not normally given neoadjuvant chemoradiotherapy”, they write.

The commentators also note that the study did not directly compare the oncological safety of deferred surgery with prompt resection. They therefore conclude: “Although the study of Appelt and colleagues is a valuable contribution to the evidence base of watchful waiting for patients with low rectal cancer, no consensus has been made on policies for optimum selection of patients, method of imaging, assessment of clinical complete response, follow-up, and chemoradiotherapy regimen.

“More data and long-term outcomes are needed before this strategy could be safely incorporated into medical practice for suitable patients.”

References

Appelt AL, Ploen J, Harling H, et al. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol 2015; Advance online publication 5 July. DOI: dx.doi.org/10.1016/S1470-2045(15)00120-5

Breugom AJ, van de Velde CJH. Is it time for watchful waiting for rectal cancer? Lancet Oncol 2015; Advance online publication 5 July. DOI: dx.doi.org/10.1016/S1470-2045(15)00015-7

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