Global BulletinAll NewsFDA Approval AlertWomen in Oncology
Expert InterviewsAround the PracticeBetween the LinesFace OffFrom All AnglesMeeting of the MindsOncViewPodcastsTraining AcademyTreatment Algorithms with the Oncology Brothers
Conferences
All JournalsEditorial BoardFor AuthorsYear in Review
Frontline ForumSatellite Sessions
CME/CE
Awareness MonthInteractive ToolsNurse Practitioners/Physician's AssistantsPartnersSponsoredSponsored Media
Career CenterSubscribe
Adverse Effects
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
Lymphoma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
Spotlight -
  • Around the Practice
  • Between the Lines
  • Contemporary Concepts
  • Journal
  • OncView
  • Podcasts
  • Readout 360
  • Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice
  • Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer
Adverse Effects
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
Lymphoma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
    • Conferences
    • CME/CE
    • Career Center
    • Subscribe
Advertisement

Adding oxaliplatin to FULV trends toward better survival in stage II/III colon cancer

September 1, 2008
By Susan London
Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 17 No 9
Volume 17
Issue 9

CHICAGO-In the adjuvant treatment of colon cancer, addition of oxaliplatin (Eloxatin) to the FULV regimen is associated with a near-significant 15% relative reduction in the risk of death, according to results from a National Surgical Adjuvant Breast and Bowel Project trial (NSABP C-07).

ABSTRACT: Data further suggest that 5 years may be too short to adequately assess differences in overall survival.

CHICAGO-In the adjuvant treatment of colon cancer, addition of oxaliplatin (Eloxatin) to the FULV regimen is associated with a near-significant 15% relative reduction in the risk of death, according to results from a National Surgical Adjuvant Breast and Bowel Project trial (NSABP C-07).

 

In the trial, patients who had undergone curative resection of stage II or III colon cancer were randomized to the weekly, bolus-based 5-FU/leucovorin regimen alone or with the addition of oxaliplatin, the so-called FLOX regimen, said lead author Norman Wolmark, MD, chairman of human oncology at Allegheny General Hospital, Pittsburgh. The updated analysis was based on 1,209 patients in the FULV arm and 1,200 patients in the FLOX arm; median follow-up was 67 months.

 

The estimated 5-year rate of disease-free survival (the trial’s primary endpoint) was 64% with FULV and 69% with FLOX, corresponding to a significant 19% relative reduction in the risk of events with the latter regimen (hazard ratio 0.81).

 

“The advantages we reported previously relative to disease-free survival are very much apparent, are robust, and are durable,” Dr. Wolmark said in a talk at ASCO 2008 (abstract LBA4005). In addition, the benefit was similar in subgroups stratified by age and by number of positive nodes.

 

The estimated rate of overall survival was 78% with FULV and 80% with FLOX at 5 years, corresponding to a near-significant 15% relative reduction in the risk of death with the latter regimen (HR 0.85, P = .06), and the difference increased at 6 years (74% vs 78%). The actual number of deaths fell short of the predicted number (based on NSABP C-04 results), reducing the trial’s power to detect a difference in this outcome, Dr. Wolmark noted.

 

The overall survival findings were similar in groups stratified by age and in patients with stage III disease, but in the 29% of patients with stage II disease, the hazard ratio exceeded 1.0. “There are some who have claimed that stage II patients do not have an incremental survival benefit when oxaliplatin is added,” Dr. Wolmark said, showing a forest plot of the subset analyses. “But look at these confidence intervals. They’re enormous. So any story that you make relative to stage II disease is probably fraught with more fable than it is with fact.”

 

Dr. Wolmark remarked that the overall survival data were nearly identical to those of the MOSAIC adjuvant trial (Andre T et al: N Engl J Med 350:2343-2351, 2004), which tested the addition of oxaliplatin to infusion-based FULV among patients with stage II or III colon cancer.

 

“The durable consistency between the results of C-07 and MOSAIC validates the benefit of oxaliplatin,” he said.

 

Longer follow-up needed

 

In the larger context, he noted, median survival after recurrence has increased significantly

across four recent NSABP trials in stage II/III colon cancer (see Figure). “So clearly, the estimates that were derived from C-04 do not apply to the current generation of adjuvant trials and certainly not the future generation of adjuvant trials,” he said.

 

He also pointed to another “interesting phenomenon”: In the C-07 trial, median survival after recurrence was significantly better with FULV than with FLOX (22 vs 18 months). “Longer follow-up-certainly greater than 5 years--in future colon cancer adjuvant trials appears to be appropriate to reliably detect a survival benefit,” Dr. Wolmark concluded.

 

Articles in this issue

Japanese team discovers more cancer fallout
Panel pans FDG-PET for new Medicare oncology coverage
Sen. Kennedy's brain tumor puts spotlight on new treatment
Precise resection in colon cancer may boost survival
Payer’s budget to get right targeted drug to right patient
Should HER2-targeted therapies be used to treat HER2-negative breast cancers?
PET brings treatment changes in majority of colon ca cases
High death rate brings prostate ca vaccine trial to a halt
Radiofrequency ablation eliminates nondysplastic BE
Childhood cancer research gets $30 million from feds
Amgen scores FDA approval for low-platelet treatment
Radiation Oncology Institute launched with $5 million ASTRO grant
PET/CT, 3T MRI perform equally well in lung cancer staging
Poll results: Improved PFS suffices for FDA approvals
Vienna hospitals call ‘Crocs’ dangerous

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Subscribe Now!
Recent Videos
Testing a patient’s genetics may influence decisions such as using longer courses of radiotherapy, says Rachit Kumar, MD.
Spatial transcriptomics and multiplex immunohistochemistry from samples may elucidate outcomes for patients who undergo surgical care for cancer.
Future work may focus on optimizing symptom management associated with percutaneous transesophageal gastrostomy placement in malignant bowel obstructions.
Post-operative length of stay ranged from 4 to 9 days for patients who underwent percutaneous transesophageal gastrostomy for malignant bowel obstructions.
Treatment with KRAS inhibitors may help mitigate a common driver of genetic alteration across a majority of pancreatic cancers.
Various methods of communication ensure that members from radiation oncology, pathology, and other departments are on the same page regarding treatment.
Updated results from the BREAKWATER study seemed to be most impactful to the CRC space, according to Michael J. Pishvaian, MD, PhD.
Related Content

Patients with MSS tumors diagnosed with metastatic CRC did not experience enhanced OS outcomes with frontline ICI therapy compared with chemotherapy.

Frontline ICI Therapy Confers OS Benefit in MSI-H Metastatic CRC

Roman Fabbricatore
May 8th 2025
Article

Patients with MSS tumors diagnosed with metastatic CRC did not experience enhanced OS outcomes with frontline ICI therapy compared with chemotherapy.


The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.

Sotorasib Combo Approval May Address Novel Therapy Need in KRAS G12C+ CRC

Marwan G. Fakih, MD
February 24th 2025
Podcast

The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.


Pathological complete response was higher among patients with ERBB2–positive gastric cancer or GEJ adenocarcinoma treated with atezolizumab vs without.

Atezolizumab/Trastuzumab Plus Chemotherapy Shows Efficacy in Gastric Cancer

Roman Fabbricatore
May 7th 2025
Article

Pathological complete response was higher among patients with ERBB2–positive gastric cancer or GEJ adenocarcinoma treated with atezolizumab vs without.


Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.

Educating Patients and Clinicians on End-of-Life Care and Discussions

Kelley A. Rone, DNP, RN, AGNP-c
November 11th 2024
Podcast

Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.


KN026/Chemotherapy Meets PFS End Point in HER2+ Gastric Cancer in 2L Setting

KN026/Chemotherapy Meets PFS End Point in HER2+ Gastric Cancer in 2L Setting

Tim Cortese
May 1st 2025
Article

Results from the phase 2/3 trial also show a favorable OS trend for KN026 with chemotherapy vs placebo with chemotherapy in HER2-positive gastric cancer.


Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.

Hypofractionated RT Shows Portal Vein Tumor Thrombosis Control, OS in HCC

Roman Fabbricatore
April 29th 2025
Article

Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.

Related Content

Patients with MSS tumors diagnosed with metastatic CRC did not experience enhanced OS outcomes with frontline ICI therapy compared with chemotherapy.

Frontline ICI Therapy Confers OS Benefit in MSI-H Metastatic CRC

Roman Fabbricatore
May 8th 2025
Article

Patients with MSS tumors diagnosed with metastatic CRC did not experience enhanced OS outcomes with frontline ICI therapy compared with chemotherapy.


The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.

Sotorasib Combo Approval May Address Novel Therapy Need in KRAS G12C+ CRC

Marwan G. Fakih, MD
February 24th 2025
Podcast

The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.


Pathological complete response was higher among patients with ERBB2–positive gastric cancer or GEJ adenocarcinoma treated with atezolizumab vs without.

Atezolizumab/Trastuzumab Plus Chemotherapy Shows Efficacy in Gastric Cancer

Roman Fabbricatore
May 7th 2025
Article

Pathological complete response was higher among patients with ERBB2–positive gastric cancer or GEJ adenocarcinoma treated with atezolizumab vs without.


Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.

Educating Patients and Clinicians on End-of-Life Care and Discussions

Kelley A. Rone, DNP, RN, AGNP-c
November 11th 2024
Podcast

Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.


KN026/Chemotherapy Meets PFS End Point in HER2+ Gastric Cancer in 2L Setting

KN026/Chemotherapy Meets PFS End Point in HER2+ Gastric Cancer in 2L Setting

Tim Cortese
May 1st 2025
Article

Results from the phase 2/3 trial also show a favorable OS trend for KN026 with chemotherapy vs placebo with chemotherapy in HER2-positive gastric cancer.


Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.

Hypofractionated RT Shows Portal Vein Tumor Thrombosis Control, OS in HCC

Roman Fabbricatore
April 29th 2025
Article

Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.

Advertisement
About
Advertise
CureToday.com
OncLive.com
OncNursingNews.com
TargetedOnc.com
Editorial
Contact
Terms and Conditions
Privacy
Do Not Sell My Personal Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.