Intensive local-regional tumor debulking in addition to standard palliative chemotherapy may not impact the overall quality of life of patients with metastatic colorectal cancer, according to a novel study published by Bakkerus et al in JNCCN–Journal of the National Comprehensive Cancer Network.
Background
“Tumor debulking for patients with synchronous oligometastatic colorectal cancer is often utilized for curative intent and endorsed in the [National Comprehensive Cancer Network® (NCCN®)] Guidelines, with surgical resection preferred over other acceptable treatment modalities such as radiation therapy or thermal ablation. However, the potential survival benefits for such interventions have not been established for patients with multiorgan rather than single-organ colorectal cancer metastases. That’s a question that the ORCHESTRA trial is attempting to answer,” said Charles J. Schneider, MD, FACP, Professor of Clinical Medicine at the Perelman School of Medicine as well as a gastrointestinal medical oncologist at the Abramson Cancer Center at the University of Pennsylvania and a member of the NCCN Clinical Practice Guidelines in Oncology Panel for Colon/Rectal/Anal Cancers, who was not involved in the study.
Study Methods and Results
In the new study, the investigators examined the outcomes of 300 patients who were involved in the ongoing ORCHESTRA trial (ClinicalTrials.gov identifier NCT01792934) and were randomly assigned to receive either standard palliative chemotherapy alone or palliative chemotherapy in addition to surgery, ablative therapy, and/or radiotherapy to reduce their tumor burden.
The investigators analyzed the results of the trial’s preplanned exploratory secondary endpoint of health-related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 and the Multidimensional Fatigue Inventory questionnaire at prespecified time points during treatment. The patients in the combination treatment group received first-line fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine plus oxaliplatin (CAPOX) in addition to or without bevacizumab plus multiorgan debulking to reduce the tumor by at least 80%.
The researchers reported that serious adverse events were observed in 21% of the patients in the standard chemotherapy alone group and 43% of the patients who received tumor debulking. However, there were no statistically significant or clinically relevant differences according to patient-reported outcomes for overall health-related quality of life or fatigue.
Conclusions
“This could mean that the negative impact of complications on quality of life is temporary and eventually balances out with a decrease in tumor-related symptoms after treatment. Patients might also adapt their [health-related quality-of-life] perceptions during the course of their disease and treatment.” suggested lead study author Lotte Bakkerus, MD, of the Radboud Institute for Health Sciences.
“Given the considerable amount of complications from local treatment, we had expected to see a bigger impact on overall and persistent quality of life in the experimental group. The fact that local therapy–associated serious side effects did not translate to a noticeable dip in the patients' perceived quality of life is quite intriguing and warrants further exploration. These results, including the risk of complications, should be taken into account in the consultation room in order to decide—together with the patient—what the right treatment choice is for each individual,” Dr. Bakkerus underscored.
“The outcome of no statistically significant or clinically relevant differences in [health-related quality of life] and fatigue after 1 year was surprising. More intriguing yet is the fact that although the patients in the intervention group experienced local treatment-related serious adverse events twice as often as patients in the standard group, there was a striking lack of association between the occurrence of [serious adverse events] and impact on [health-related quality of life]. Thus, this [health-related quality of life] equivalence—even in the face of twice as many [serious adverse events] in the intervention group—should give guarded justification for multiorgan tumor debulking combined with palliative chemotherapy in select patients if the survival data turns out to favor the intervention group as well,” Dr. Schneider concluded.
Disclosure: For full disclosures of the study authors, visit jnccn.org.
