In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 329-329
Abstract:
329 Background: We have entered an era where multiple chemotherapeutic (chemo) agents can be utilized in the treatment (Tx) of patients (pts) with MPC. However, there are no methods for selecting the optimal regimen for any individual pt, and pure empiricism has not proven to be an optimal strategy. Molecular profiling is now widely used, albeit without evidence-based studies linking molecular profiles to Tx choices. Methods: We initiated a pilot study to assess the feasibility of following a simple algorithm, basing Tx on 3 published predictive markers of response to chemo: RRM1 (for gemcitabine); ERCC1 (for platinums); and TS (for 5FU). Pts with untreated, biopsiable MPC were eligible. Tissue biopsies were analyzed by Caris, and the results used to assign pts to 1 of 7 doublet regimens. Our 1 o objective was to provide preliminary data to inform a larger, randomized trial. Key 2 o objectives included assessment of the response rate (RR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Results: Between 12-2012 and 08-2014, 26 pts were enrolled. Eleven failed screening primarily due to inadequate tumor tissue availability (and pts not wanting to wait for a 2 nd biopsy). Of the 15 pts profiled, 6 different doublets were assigned, reflecting the breadth of profile results. Three pts were not evaluable for response by the date of this abstract. Of the 12 pts who received Tx, the RR was 9%, but the DCR rate was 82%. The median PFS and OS were 5.9 and 10.4 months, respectively. Conclusions: The incorporation of chemo biomarkers is feasible and resulted in a promising PFS and OS for pts with MPC. Our pilot experience suggests that there may be value to assessing a pt’s tumor molecular profile to select Tx. Expansion of this experience into a randomized trial of profile-directed Tx vs. Tx based on the physician’s discretion would not only be realistic, but could be critical to realizing the full, clinically meaningful benefit of molecular profiling. We do however caution that biomarker-directed Tx can be challenging in untreated pts, where initiation of Tx is time critical, and delays due to inadequate tumor samples may be untenable. Thus, a randomized trial in the second line setting may be more appropriate. Clinical trial information: NCT01888978.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2015.33.3_suppl.329
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2015
detail.hit.zdb_id:
2005181-5
detail.hit.zdb_id:
604914-X
