Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14

Article

Author: Muller, Carolyn Y. ; Holman, Laura L ; Powell, Matthew A ; Bookman, Michael A. ; Tew, William P ; Sood, Anil K. ; Holman, Laura L. ; Tew, William P. ; Gershenson, David M ; Crane, Erin ; Schorge, John ; Miller, David S. ; Gershenson, David M. ; Bookman, Michael A ; Backes, Floor ; Miller, Austin ; Nagel, Christa ; Powell, Matthew A. ; Westin, Shannon N. ; Sood, Anil K ; Muller, Carolyn Y ; Bender, David ; Westin, Shannon N ; Secord, Angeles Alvarez ; Brown, Jubilee ; Miller, David S ; Bonebrake, Albert ; Aghajanian, Carol

OBJECTIVESTo assess the efficacy and toxicity of paclitaxel and carboplatin (PC) compared to bleomycin, etoposide, and cisplatin (BEP) for treatment of newly diagnosed Stage IIA-IV or recurrent chemotherapy-naive ovarian sex cord-stromal tumors (SCST).METHODSThis phase II noninferiority trial randomly assigned patients to receive PC (6 cycles P 175 mg/m2 and C AUC = 6 IV every 3 weeks), or BEP (4 cycles B 20 units/m2 IV push day 1, E 75 mg/m2 IV days 1-5, and cisplatin 20 mg/m2 IV days 1-5 every 3 weeks). The primary endpoint was progression- free survival (PFS). This trial is registered with ClinicalTrials.gov, NCT01042522.RESULTSAt the interim analysis, 63 patients (31 PC and 32 B.P. had accrued between Feb 8, 2010 and Apr 30, 2020. Median age was 48 years. 87% had granulosa cell tumors. 37% had measurable disease. The DSMB closed accrual early for futility of PC arm. The futility analysis was supported by an estimated HR = 1.11 [95% CI: 0.57 to 2.13] which exceeded the pre-determined threshold for non-inferiority (1.10). Median PFS was 27.7 months [11.2 to 41.0] for PC and 19.7 months for BEP [95% CI: 10.4-52.7]. PC patients had fewer grade 3 or higher adverse events (PC 77% vs BEP 90%).CONCLUSIONSThe study met its pre-specified criterion for stopping early for futility and so failed to demonstrate non-inferiority of PC versus BEP in ovarian SCSTs, in a non-inferiority test with a hazard ratio margin of 1.1. Both PC and BEP may be considered in patients with advanced/recurrent SCST.

01 Nov 2023·JCO Oncology Practice

Loss to primary care provider follow-up among survivors five to seven years post-diagnosis.

Author: Isom, Scott ; Randazzo, Aliza ; Weaver, Kathryn E. ; Falk, Derek Sean ; Shalowitz, David I. ; Bell, Ronny A. ; Birken, Sarah A. ; Peluso, Alexandra G. ; Wagi, Cheyenne R.

331 Background: Cancer survivors experience better outcomes when primary care providers (PCPs) are engaged in their care. Several studies indicate that nearly all survivors have ≥1 PCP visits per year in the initial five years post-diagnosis; however, little is known about sustained PCP engagement in survivors’ care. Our objective was to assess PCP engagement in survivors’ care 5-7 years post-diagnosis, and to characterize survivors who are most vulnerable to loss to PCP follow-up. Methods: We linked electronic health record ambulatory care visit data to Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) registry data to identify survivors who were (1) ages ≥18 years, (2) diagnosed with a breast, colorectal, or uterine cancer between January 1, 2014 and December 31, 2015, (3) treated at AHWFBCCC as of September 1, 2019, and (4) had a PCP in the WF Health Network. We used multiple logistic regression to assess associations between survivor demographics, clinical factors, and healthcare utilization and odds of sustained PCP engagement in care, defined as having at least one ambulatory visit per year with a family or internal medicine provider. Results: There were 638 survivors who met our inclusion criteria. Of these, 122 died within the six-year post-diagnosis period and were excluded from analysis. Our analytic sample included 516 survivors who were primarily female (88.4%), white (75.0%), non-Hispanic (95.7%) stage 1 (50.6%) breast cancer survivors (69.2%) with a mean age of 60.7 years. Most (84.7%) survivors lived in an urban area at the time of diagnosis. In years 5-7 post-diagnosis, PCPs were engaged in care for 43% of survivors. Survivors with sustained PCP-engagement were on average 4.6 years older than those without (p<0.0001); survivors had 1.36 greater odds of having regular PCP visits for each decade increase in their age upon cancer diagnosis (p=0.0030). Survivors were less likely to be lost to PCP follow-up in if they were diagnosed at an earlier stage (p=0.0005) and had at least one visit annually with an oncologist 5-7 years post-diagnosis (p<0.0001). Conclusions: Sustained PCP engagement has been endorsed as critical by survivors, PCPs, and oncologists. In this study, we found that in the 5-7 years post-diagnosis, most (57%) survivors were lost to PCP follow-up. Older survivors, those currently engaged in oncology care, and survivors with earlier stage cancer were less likely to be lost to PCP follow-up, perhaps attributable to higher overall healthcare utilization. Our study may overestimate loss to PCP follow-up since we were unable to assess PCP visits outside of the AHWFB network; however, our findings offer evidence in support of calls for interventions to promote sustained PCP engagement among survivors, including the information, care coordination, and self-management support that survivors and PCPs have consistently reported needing for improved survivorship care and outcomes.

04 Mar 2023·Journal of Psychosocial OncologyQ4 · MEDICINE

Partner presence in clinical conversations about sexual health: Breast cancer survivors’, partners’, and providers’ perspectives of triadic interactions

Q4 · MEDICINE

Article

Author: Fisher, Carla L. ; Dong, Thrandia ; Canzona, Mollie Rose ; Garcia, David S. ; Ledford, Christy J. W.

PURPOSEBreast cancer survivors' (BCSs') sexual health (SH) clinical conversations are rarely studied from a dyadic perspective let alone from a triadic perspective. Using a triadic approach, we evaluated BCSs' comfort discussing SH with partners present and identified factors that can contribute to their comfort level.DESIGNQualitative approach using in-depth interviews.PARTICIPANTS93 BCSs, partners, and providers involved in BCS care.METHODSIn-depth interviews with BCSs, partners, and providers explored triadic perspectives to understand factors informing BCSs' comfort level. Thematic analysis was used to analyze data.FINDINGSFour themes characterize potential benefits of partner presence: 1) partner facilitates information exchange, 2) partner realizes BCS's SH concerns are "a real thing," 3) partner better understands SH challenges, and 4) partner presence encourages relational communication about SH. Five themes illustrate potential complications of partner presence: 1) partner feels/becomes embarrassed, 2) partner is/becomes defensive, 3) partner presence constrains BCS's agency in clinical conversations, 4) partner presence threatens partner's view of BCS as a sexual being, and 5) partner presence increases partner burden.IMPLICATIONS FOR PSYCHOSOCIAL ONCOLOGYProviders should (1) initiate conversations about BCS comfort with partner presence, (2) be aware of the interaction between BCS primary and secondary goals, (3) consider how BCS/partner goal conflicts obstruct BCS agency and sexual/relational health, and (4) offer opportunities to clarify goals and expectations, and coordinate therapeutic options.

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