Limits...
Barriers prevent patient access to personalized therapies identified by molecular tumor profiling of gynecologic malignancies.

Hillman RT, Ward K, Saenz C, McHale M, Plaxe S - J Pers Med (2015)

Bottom Line: Tumor profiling identified no clinically actionable mutations for seven patients (27%).Six patients sought insurance approval for a targeted therapy and two were declined (33%).One patient (4%) received a targeted therapy and this was discontinued due to tumor progression.

View Article: PubMed Central - PubMed

Affiliation: Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA. rhillman@ucsd.edu.

ABSTRACT

Objective: This study was designed to evaluate the ability of commercial molecular tumor profiling to discover actionable mutations and to identify barriers that might prevent patient access to personalized therapies.

Methods: We conducted an IRB-approved retrospective review of 26 patients with gynecologic malignancies who underwent commercial tumor profiling at our institution during the first 18 months of test availability. Tumor profiles reported targeted therapies and clinical trials matched to patient-specific mutations. Data analysis consisted of descriptive statistics.

Results: Most patients who underwent tumor profiling had serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (46%). Patients underwent profiling after undergoing a median of two systemic therapies (range 0 to 13). A median of one targeted therapy was suggested per patient profile. Tumor profiling identified no clinically actionable mutations for seven patients (27%). Six patients sought insurance approval for a targeted therapy and two were declined (33%). One patient (4%) received a targeted therapy and this was discontinued due to tumor progression.

Conclusions: There are formidable barriers to targeted therapy for patients with gynecologic malignancies. These barriers include a dearth of FDA-approved targeted agents for gynecologic malignancies, lack of third party insurance coverage and limited geographic availability of clinical trials.

No MeSH data available.


Related in: MedlinePlus

Progression-free survival of patients who had personalized therapy declined by insurance as compared to all other patients who underwent FoundationOne testing. Kaplan-Meier plot of progression-free survival in months for patients who applied for insurance reimbursement for personalized therapy based on FoundationOne result and had reimbursement declined (red line) as compared to all other patients who underwent FoundationOne testing (blue line). Progression-free survival was not significantly different between these groups (p = 0.334, Log Rank comparison). Cross-hatch lines represent data censored by the end of study period or when patient lost to follow up.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4493494&req=5

jpm-05-00165-f002: Progression-free survival of patients who had personalized therapy declined by insurance as compared to all other patients who underwent FoundationOne testing. Kaplan-Meier plot of progression-free survival in months for patients who applied for insurance reimbursement for personalized therapy based on FoundationOne result and had reimbursement declined (red line) as compared to all other patients who underwent FoundationOne testing (blue line). Progression-free survival was not significantly different between these groups (p = 0.334, Log Rank comparison). Cross-hatch lines represent data censored by the end of study period or when patient lost to follow up.

Mentions: Among the 19 patients for whom a relevant FDA approved targeted therapy was identified by tumor profiling, six patients (31.5%) did not pursue a targeted therapy because they achieved an interval response to conventional treatment and three patients (15.7%) declined a targeted therapy when it was offered. A total of six patients sought insurance approval for a targeted therapy and two were declined (33% of those who sought approval). Median progression-free survival for patients who sought insurance approval for targeted therapy and were declined was 4 months (95% CI 0–9.8) and was not significantly different from the progression-free survival of 5 months (95% CI 2.3–7.7) for all other patients who underwent FoundationOneTM testing (p = 0.334, Log Rank test) (Appendix Figure A1). Overall only one patient who underwent FoundationOneTM tumor profiling for a gynecologic malignancy at our institution received a targeted therapy based on the tumor profile (1 of 26, 4%). This targeted therapy (ruxolitinib) was discontinued after a short period of treatment due to tumor progression, and the patient succumbed to her disease several months later. The most common targeted therapies suggested by FoundationOneTM tumor profiling were everolimus/temsirolimus (suggested in 8/26 profiles, 30%) and trametinib (suggested in 8/26 profiles, 30%).


Barriers prevent patient access to personalized therapies identified by molecular tumor profiling of gynecologic malignancies.

Hillman RT, Ward K, Saenz C, McHale M, Plaxe S - J Pers Med (2015)

Progression-free survival of patients who had personalized therapy declined by insurance as compared to all other patients who underwent FoundationOne testing. Kaplan-Meier plot of progression-free survival in months for patients who applied for insurance reimbursement for personalized therapy based on FoundationOne result and had reimbursement declined (red line) as compared to all other patients who underwent FoundationOne testing (blue line). Progression-free survival was not significantly different between these groups (p = 0.334, Log Rank comparison). Cross-hatch lines represent data censored by the end of study period or when patient lost to follow up.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4493494&req=5

jpm-05-00165-f002: Progression-free survival of patients who had personalized therapy declined by insurance as compared to all other patients who underwent FoundationOne testing. Kaplan-Meier plot of progression-free survival in months for patients who applied for insurance reimbursement for personalized therapy based on FoundationOne result and had reimbursement declined (red line) as compared to all other patients who underwent FoundationOne testing (blue line). Progression-free survival was not significantly different between these groups (p = 0.334, Log Rank comparison). Cross-hatch lines represent data censored by the end of study period or when patient lost to follow up.
Mentions: Among the 19 patients for whom a relevant FDA approved targeted therapy was identified by tumor profiling, six patients (31.5%) did not pursue a targeted therapy because they achieved an interval response to conventional treatment and three patients (15.7%) declined a targeted therapy when it was offered. A total of six patients sought insurance approval for a targeted therapy and two were declined (33% of those who sought approval). Median progression-free survival for patients who sought insurance approval for targeted therapy and were declined was 4 months (95% CI 0–9.8) and was not significantly different from the progression-free survival of 5 months (95% CI 2.3–7.7) for all other patients who underwent FoundationOneTM testing (p = 0.334, Log Rank test) (Appendix Figure A1). Overall only one patient who underwent FoundationOneTM tumor profiling for a gynecologic malignancy at our institution received a targeted therapy based on the tumor profile (1 of 26, 4%). This targeted therapy (ruxolitinib) was discontinued after a short period of treatment due to tumor progression, and the patient succumbed to her disease several months later. The most common targeted therapies suggested by FoundationOneTM tumor profiling were everolimus/temsirolimus (suggested in 8/26 profiles, 30%) and trametinib (suggested in 8/26 profiles, 30%).

Bottom Line: Tumor profiling identified no clinically actionable mutations for seven patients (27%).Six patients sought insurance approval for a targeted therapy and two were declined (33%).One patient (4%) received a targeted therapy and this was discontinued due to tumor progression.

View Article: PubMed Central - PubMed

Affiliation: Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA. rhillman@ucsd.edu.

ABSTRACT

Objective: This study was designed to evaluate the ability of commercial molecular tumor profiling to discover actionable mutations and to identify barriers that might prevent patient access to personalized therapies.

Methods: We conducted an IRB-approved retrospective review of 26 patients with gynecologic malignancies who underwent commercial tumor profiling at our institution during the first 18 months of test availability. Tumor profiles reported targeted therapies and clinical trials matched to patient-specific mutations. Data analysis consisted of descriptive statistics.

Results: Most patients who underwent tumor profiling had serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (46%). Patients underwent profiling after undergoing a median of two systemic therapies (range 0 to 13). A median of one targeted therapy was suggested per patient profile. Tumor profiling identified no clinically actionable mutations for seven patients (27%). Six patients sought insurance approval for a targeted therapy and two were declined (33%). One patient (4%) received a targeted therapy and this was discontinued due to tumor progression.

Conclusions: There are formidable barriers to targeted therapy for patients with gynecologic malignancies. These barriers include a dearth of FDA-approved targeted agents for gynecologic malignancies, lack of third party insurance coverage and limited geographic availability of clinical trials.

No MeSH data available.


Related in: MedlinePlus