Staged or Simultaneous Surgery for Colon or Rectal Cancer with Synchronous Liver Metastases: Implications for Study Design and Clinical Endpoints
Abstract
:Simple Summary
Abstract
1. Introduction
2. Current Knowledge Gaps
- The number of liver metastases that is considered safe to resect;
- The number of liver resections or liver segments that is considered safe to resect;
- The size of the future liver remnant that is considered safe (for simultaneous surgery);
- The timing of staged resection (liver or primary tumor first);
- Whether chemotherapy should be administered before or after surgery (or if at all);
- Oncological endpoints (recurrence, time to recurrence, survival, etc.);
- Quality of life;
- Health economics.
3. Endpoints—Which One and for What Trial Design?
4. Surgery-Related Endpoints and Complications
5. Short-Term Outcomes
6. Long-Term Outcomes and Survival
7. Why a Composite Endpoint?
8. Other Related Endpoints to Consider
- EORTC-QLQ-30 (designed to measure cancer patients physical, psychological, and social functions);
- QLQ-CR29 (QoL measurement disease-specific for colorectal cancer);
- QLQ-LM21 (QoL measurement disease-specific for CRLM);
- EQ-5D-5L (measuring health-related QoL).
9. Who Should Be Included in a Surgical Trial?
9.1. Staged or Simultaneous Surgery?
9.2. Tumor Biology and Molecular Markers—Any Role?
10. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Yaqub, S.; Margonis, G.A.; Søreide, K. Staged or Simultaneous Surgery for Colon or Rectal Cancer with Synchronous Liver Metastases: Implications for Study Design and Clinical Endpoints. Cancers 2023, 15, 2177. https://doi.org/10.3390/cancers15072177
Yaqub S, Margonis GA, Søreide K. Staged or Simultaneous Surgery for Colon or Rectal Cancer with Synchronous Liver Metastases: Implications for Study Design and Clinical Endpoints. Cancers. 2023; 15(7):2177. https://doi.org/10.3390/cancers15072177
Chicago/Turabian StyleYaqub, Sheraz, Georgios Antonios Margonis, and Kjetil Søreide. 2023. "Staged or Simultaneous Surgery for Colon or Rectal Cancer with Synchronous Liver Metastases: Implications for Study Design and Clinical Endpoints" Cancers 15, no. 7: 2177. https://doi.org/10.3390/cancers15072177
APA StyleYaqub, S., Margonis, G. A., & Søreide, K. (2023). Staged or Simultaneous Surgery for Colon or Rectal Cancer with Synchronous Liver Metastases: Implications for Study Design and Clinical Endpoints. Cancers, 15(7), 2177. https://doi.org/10.3390/cancers15072177