Global BulletinAll NewsFDA Approval AlertWomen in Oncology
Around the PracticeBetween the LinesFace OffFrom All AnglesMeeting of the MindsOncViewPodcastsTraining AcademyTreatment Algorithms with the Oncology BrothersVideos
Conferences
All JournalsEditorial BoardFor AuthorsYear in Review
Frontline ForumSatellite Sessions
CME/CE
Awareness MonthNurse 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 -
  • Radiation Oncology
  • Surgery
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

Drug Combo Reduced Polyps in Patients With CRC-Related Familial Disorder

March 22, 2016
By Leah Lawrence
Article

The combination use of sulindac and erlotinib significantly reduced the number of small intestine, or duodenal, polyps present in patients with familial adenomatous polyposis.

FAP is associated with the formation of hundreds or thousands of polyps in the colorectum

The combination use of sulindac and erlotinib significantly reduced the number of small intestine, or duodenal, polyps present in patients with familial adenomatous polyposis (FAP), an inherited disorder associated with an increased risk for colorectal cancer.

A study looking at the drug combination in 46 patients with FAP was stopped early when an interim analysis showed the superiority of the drug combination in comparison with placebo.

“Further research is necessary to evaluate these preliminary findings in a larger study population with longer follow-up to determine whether the observed effects will result in improved clinical outcomes,” study researcher N. Jewel Samadder, MD, of Huntsman Cancer Institute, University of Utah, and colleagues wrote in JAMA.

According to the study, FAP is associated with the formation of hundreds or thousands of polyps in the colorectum, and when left untreated, close to 100% of people with the disorder eventually develop colorectal cancer. Many people with the disorder undergo prophylactic colectomy; however, they still run a high risk of developing duodenal polyps and adenocarcinoma.

In this study, Samadder and colleagues examined the efficacy of the non-steroidal anti-inflammatory drug sulindac, with erlotinib, an EGFR inhibitor, to see if their use would reduce the number and burden of duodenal polyps in patients with FAP. They randomly assigned patients to sulindac 150 mg twice daily plus erlotinib 75 mg daily (n = 46) or placebo (n = 46), and compared the presence of polyps at baseline and 6 months.

At a second planned interim analysis the trial was halted. At 6 months, patients assigned the combination had 8.5-mm median decrease in polyp burden-sum diameter of polyps-compared with a 8-mm median increase in polyp burden in patients assigned placebo (P < .001). This translated into a 30.6% increase in polyp burden for patients assigned placebo compared with a 37.9% decrease in burden related to the drug combination.

Patients assigned the drug combination also had significant improvement in the median duodenal polyp count compared with placebo (-2.8 vs 4.3; P < .001). Significant improvement in polyp burden was seen in patients with both classic FAP or attenuated FAP.

Patients assigned the drug combination experienced a higher rate of grade 1 and 2 adverse events including acne-like rash in 87% of participants compared with 20% of participants assigned placebo (P < .001).

“Although the dosing of sulindac was based on prior chemoprevention studies, the dosing of erlotinib was estimated from cancer treatment and lung cancer chemotherapy trials,” the researchers noted. “Dose-ranging studies will be needed to determine if lower and/or less frequent dosing of erlotinib could diminish these adverse effects, but retain efficacy.”

In their discussion of the results, the researchers noted several limitations to the trial. Specifically, they noted that “without long-term follow-up data, the durability of the effect of sulindac and erlotinib, the potential to develop resistance to either drug, and whether patients ultimately undergo fewer surveillance endoscopies/surgery or develop fewer cancers are unknown.”

Recent Videos
Epistemic closure, broad-scale distribution, and insurance companies are the 3 largest obstacles to implementing new peritoneal surface malignancy care guidelines into practice.
“This is something where this is written by the trainees, for the trainees, and, of course, for all the other clinicians who take care of patients,” said Kiran Turaga, MD, MPH.
“Everyone—patients, doctors—we all want the same thing. We want [patients] to live longer,” said Kiran Turaga, MD, MPH, on patients with peritoneal surface malignancies.
The new peritoneal surface malignancy care guidelines had clinicians gather from every disease state to show increased representation.
These new guidelines aim to alleviate some of the problems caused by patients with peritoneal metastases being diagnosed with the disease in late stages.
Those being treated for peritoneal carcinomatosis may not have to experience the complication rates or prolonged recovery associated with surgical options.
Related Content
Advertisement

A total of 34 patients were included in the efficacy analysis; all received 320 mg of atebimetinib once daily plus 1000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel.

Atebimetinib Plus SOC Chemo Improves Survival/Safety in 1L PDAC

Tim Cortese
September 25th 2025
Article

Atebimetinib with gemcitabine and nab-paclitaxel achieved a 9-month OS and PFS of 86% and 53%, respectively, in patients with pancreatic cancer in frontline settings.


Benjamin Golas, MD, discusses how the use of PIPAC may work in conjunction with systemic chemotherapy for those with peritoneal carcinomatosis.

Harnessing PIPAC to Improve Outcomes in Peritoneal Carcinomatosis

Benjamin J. Golas, MD
June 30th 2025
Podcast

Benjamin Golas, MD, discusses how the use of PIPAC may work in conjunction with systemic chemotherapy for those with peritoneal carcinomatosis.


analysis of biomarkers associated with outcomes from the trial was presented.3 The biomarker analysis demonstrated that intratumoral myeloid cells and T cells were activated in responding patients.

Mitazalimab/Chemo Yields Promising Survival/Responses in Untreated PDAC

Tim Cortese
September 22nd 2025
Article

At 30 months, mitazalimab plus mFOLFIRINOX achieved an OS rate of 21% in patients with previously untreated metastatic PDAC.


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.


Favorable survival outcomes were identified, overall, in the wild-type and GOF groups vs the non-GOF group.

P53 Mutations May Reveal Viability of Different Pancreatic Cancer Therapies

Tim Cortese
September 20th 2025
Article

Patients with PDAC and non-GOF mutations had less favorable OS and DFS outcomes in various instances compared with those who had wild-type or GOF mutations.


An independent data monitoring committee recommended the continuation of the phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in PDAC in August 2025.

ELI-002 7P Elicits T Cell Responses in Mutant KRAS-Driven Tumors

Roman Fabbricatore
September 18th 2025
Article

An independent data monitoring committee recommended the continuation of the phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in PDAC in August 2025.

Related Content
Advertisement

A total of 34 patients were included in the efficacy analysis; all received 320 mg of atebimetinib once daily plus 1000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel.

Atebimetinib Plus SOC Chemo Improves Survival/Safety in 1L PDAC

Tim Cortese
September 25th 2025
Article

Atebimetinib with gemcitabine and nab-paclitaxel achieved a 9-month OS and PFS of 86% and 53%, respectively, in patients with pancreatic cancer in frontline settings.


Benjamin Golas, MD, discusses how the use of PIPAC may work in conjunction with systemic chemotherapy for those with peritoneal carcinomatosis.

Harnessing PIPAC to Improve Outcomes in Peritoneal Carcinomatosis

Benjamin J. Golas, MD
June 30th 2025
Podcast

Benjamin Golas, MD, discusses how the use of PIPAC may work in conjunction with systemic chemotherapy for those with peritoneal carcinomatosis.


analysis of biomarkers associated with outcomes from the trial was presented.3 The biomarker analysis demonstrated that intratumoral myeloid cells and T cells were activated in responding patients.

Mitazalimab/Chemo Yields Promising Survival/Responses in Untreated PDAC

Tim Cortese
September 22nd 2025
Article

At 30 months, mitazalimab plus mFOLFIRINOX achieved an OS rate of 21% in patients with previously untreated metastatic PDAC.


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.


Favorable survival outcomes were identified, overall, in the wild-type and GOF groups vs the non-GOF group.

P53 Mutations May Reveal Viability of Different Pancreatic Cancer Therapies

Tim Cortese
September 20th 2025
Article

Patients with PDAC and non-GOF mutations had less favorable OS and DFS outcomes in various instances compared with those who had wild-type or GOF mutations.


An independent data monitoring committee recommended the continuation of the phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in PDAC in August 2025.

ELI-002 7P Elicits T Cell Responses in Mutant KRAS-Driven Tumors

Roman Fabbricatore
September 18th 2025
Article

An independent data monitoring committee recommended the continuation of the phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in PDAC in August 2025.

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.