Analysis of surgical salvage after failure of primary therapy in rectal cancer: results from INT 0114

Reviewer: Ryan Smith, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 18, 2002

Presenter: M O'Connell
Presenter's Affiliation: National Intergroup Trial
Type of Session: Scientific


    Although rectal cancer is usually an aggressive cancer, the resection of metastatic disease is thought to be efficacious. Although this thought is eminent among oncologists, there is little prospective data regarding the resection of single metastases in rectal cancer

Materials and Methods

  • INT 0114 was a study designed to evaluate different chemotherapy regimens in the adjuvant treatment of rectal cancer.
  • The patient population was a group of patients with T3-4 +/- lymph node positive rectal tumors, who had a potentially curative surgical procedure.
  • Adjuvant therapy consisted of 5-FU and radiation therapy in different combinations.
  • A total of 1696 patients were available for analysis with a median follow up of 8.9 years.
  • Of these patients, 721 (43%) had disease recurrence. 524 had a single site of recurrence, with full analysis available for 500 of them. These patients form the patient population for the study.


  • 167 patients had liver metastases as their single site of metastatic disease. 54 (32%) were resected.
  • 158 patients had a single site of metastatic disease in the lung, with 60 (38%) resected.
  • 123 patients had local recurrence in the pelvis as their single site of disease, with 45 patients (37%) resected.
  • Approximately 70% of the recurrences were detected via CT or CXR.
  • More patients in the resected group had an asymptomatic presentation.
  • Patients with a single recurrence did better than those with recurrences at multiple sites. There was no difference in survival among the different sites of recurrences.
  • Survival was not related to time to recurrence or by original N stage. Also, survival was statistically significantly better in those patients who had their disease resected.
  • 5 year survival in those patients with liver metastases was >25% with resection vs. <5% without resection.
  • In those patients with lung metastases, 5 year survival was >30% in those resected vs. <5% in those not resected.
  • In those patients with local recurrence, 5 year survival 23% in those resected vs. 3% in those not resected.
  • Overall, there was an approximate 27% long term survival in those patients able to be resected, which is likely a cure in many patients.

Author's Conclusions

  • 71% of patients with recurrent rectal cancer recur with a single site of disease.
  • Approximately 34% of these patients have attempted resection with curative intent. 27% of these patients have long term survial, compared to very few patients without resection.

Clinical/Scientific Implications

    This study shows that complete resection of metastatic disease is beneficial. However, although this data is prospective, it is not randomized, nor are the patients stratified by any means. Obviously, there are subsets of patients that are more likely to undergo attempts at resection. These include those with disease that indeed is anatomically resectable, those patients medically operable, and those patients with a better performance status. This obviously selects for a better group of patients that would likely have a greater survival regardless of therapy. There is no data on how many complete resections were attempted and not achieved. Also, the role for adjuvant therapy in these patients is unclear. However, the large difference in