Evaluation of the impact of comprehensive genomic profiling on clinical outcomes in gynecologic oncology patients

AbstractPurposeTissue-based comprehensive genomic profiling (CGP) is increasingly utilized for treatment selection in patients with advanced solid tumors, however real-world tissue availability may limit widespread implementation. Here we established real-world CGP tissue availability and assessed CGP performance on consecutively received samples.Patients and MethodPost-hoc, non-prespecified analysis of 32,048 consecutive tumor tissue samples received for StrataNGS, a multiplex PCR based-CGP (PCR-CGP) test, as part of an ongoing observational trial (NCT03061305). Tumor tissue sample characteristics and PCR-CGP performance were assessed across all tested tumor samples, including exception samples not meeting minimum input requirements (<20% tumor content [TC], <2mm2 tumor surface area [TSA], DNA or RNA yield <1ng/ul, or specimen age >5yrs). Tests reporting at least one prioritized alteration or meeting all sequencing QC metrics (and ≥20% TC) were considered successful. For prostate carcinoma and lung adenocarcinoma, tests reporting at least one actionable/informative alteration or those meeting all sequencing QC metrics (and ≥20% TC) were considered actionable.ResultsPCR-CGP was attempted in 31,165 of 32,048 (97.2%) consecutively received solid tumor tissue samples. Among the 31,165 tested samples, 10.7% had low (<20%) tumor content (TC) and 58.4% were small (<25mm2 TSA), highlighting the challenging nature of samples received for CGP. Of the 31,101 samples evaluable for input requirements, 8,079 (26.0%) were exceptions not meeting requirements. However, 94.2% of the 31,101 tested samples were successfully reported, including 80.6% of exception samples. Importantly, 80.6% of 1,344 tested prostate carcinomas and 87.8% of 1,144 tested lung adenocarcinomas yielded results informing treatment selection.ConclusionMost real-world tumor tissue samples from patients with advanced cancer desiring CGP are limited, requiring optimized CGP approaches to produce meaningful results. An optimized PCR-CGP test, coupled with an inclusive exception testing policy, delivered reportable results for >94% of samples, potentially expanding the proportion of CGP-testable patients, and thus the impact of biomarker-guided targeted and immunotherapies.

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PROMIS-10 scores at six months post-baseline among breast and gynecologic oncology patients participating in a text-based symptom monitoring program with patient navigation.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e19173 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e19173-e19173

Author(s):

Michelle Joy Naughton ◽

Ritu Salani ◽

Maryam B. Lustberg ◽

Juan Peng ◽

Jennifer Moon ◽

...

Keyword(s):

Mental Health ◽

Physical Health ◽

Gynecologic Oncology ◽

Monitoring Program ◽

Physical And Mental Health ◽

Improvement Program ◽

Oncology Patients ◽

Mental Health Functioning ◽

Health Functioning ◽

The Impact

e19173 Background: Unreported symptoms during cancer treatment can lead to poorer patient care and quality of life. eHealth technologies enable effective means to track patients’ health in real time to provide assistance in meeting patients’ needs and facilitating symptom management. Methods: Gynecologic (endometrial and ovarian) and breast oncology patients were enrolled in a quality improvement program post-surgically to respond to 12-monthly, text-based symptom surveys assessing fatigue, sleep quality, pain, and depression (PHQ-9). At baseline, 6 and 12 months, patients also completed the PROMIS-10 to assess their physical and mental health functioning. All patient responses were captured in REDCap and monitored by program staff, with patients’ oncologists receiving monthly feedback for patient follow-up. Patient navigators were also engaged for patients needing assistance with non-medical concerns. We provide the interim results of this program on PROMIS-10 scores from baseline to 6 months. Results: 198 breast and 120 gynecologic oncology patients (ovarian [n = 70] and endometrial [n = 50]) were enrolled. Multiple regression examined the impact of demographic (age, race, education), clinical (stage, chemotherapy, radiation), and monitoring program variables (# of monthly surveys completed, navigation services [yes/no]) on PROMIS-10 physical and mental health subscale scores at 6 months, adjusting for baseline PROMIS scores. For the breast patients, the only significant predictor of worse PROMIS physical health scores was a cancer stage of 4 vs 1 (p = 0.049), whereas a higher number of symptom surveys completed was associated with worse mental health functioning (p = 0.033). For the gynecologic oncology patients, worse PROMIS physical health scores were only associated with higher age (p = 0.037), but higher PROMIS mental health was also associated with higher age (p = 0.029) and borderline significantly associated with not using navigation services (p = 0.07). Conclusions: These results indicate that greater adherence in completing monthly symptom surveys and using navigation services were more likely to be associated with patients reporting lower mental health. PROMIS physical health scores, however, were not significantly associated with adherence to monthly surveys or navigation services. These interim results suggest that monitoring programs, such as this, may assist in identifying and treating patients with lower mental health functioning during treatment.

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