A Quality Brief of an Oncological Multisite Massage and Acupuncture Therapy Program to Improve Cancer-Related Outcomes.

Objectives: Cancer treatment can present its own physical and mental challenges resulting in symptoms such as fatigue, stress, pain, nausea, and vomiting. Aurora Health Care is a large health system with 19 cancer centers. Integrative therapies such as acupuncture and massage have demonstrated success in reducing cancer-related symptoms and side effects to conventional cancer treatment and improving patient outcomes. In 2018, 15 of the 19 Aurora Cancer Clinics embedded a replicable Integrative Cancer Care closed model to provide adjuvant therapies for the best patient outcomes. This quality improvement study aimed to explore if the replicable integrative care model could demonstrate consistent outcomes for massage and acupuncture therapies aimed at symptom reduction across multiple oncology clinics. Design: Aurora Cancer Care and Aurora Integrative Medicine designed a reproducible integrative therapy service model to be embedded into the Aurora Cancer Centers. Integrative therapies within the cancer centers allow patients easy access to care before, during, or after their cancer treatment. In 2018, 15 of the 19 cancer clinics had integrative therapies available to patients with cancer. This model required unified operations, onboarding, training, competency, and clinical oversight to achieve consistent processes for consistent outcomes. Furthermore, these innovative models prioritized the following: patient access (easy and affordable); service delivery (consistent and operationalized); clinical outcomes (effective and meaningful); and caliber of clinician (competent and confident). Aurora Health Care employs massage therapists (Mts) and acupuncturists (Ats). This employment model allows for standards and program model adherence. To achieve competent and confident clinician's, MT or AT must complete a cancer treatment-focused competency training program relative to their respective profession and adherence to practice standards outlined. The training program is built on evidence-based practice, observation, direct demonstration, return demonstration, mentorship, and ongoing quality review by clinical leaders. Aurora's Integrative Cancer Care closed model of care is accessible to patients through philanthropic funds secured to underwrite the free service of MT provided during infusion treatments. Funds also provided three free AT sessions. Ongoing acupuncture therapies were provided at a low-cost group acupuncture fee at $25.00 per treatment. Acupuncture is available in group format and provided either before or after chemotherapy treatment. The free services were intended to introduce the concept of integrative therapies as a viable adjuvant option with conventional cancer care. As this model incorporates a mix of philanthropic funding and low-cost fees to offset the cost of the therapy provider, it is referred to as a "closed model" or accessible only to those patients under the care of an Aurora Cancer specialist. In 2018, 15 Aurora Cancer Clinics offered massage and 11 Aurora Cancer Clinics offered acupuncture. Patients who self-selected integrative therapies via system-employed Mts and Ats were surveyed pre/post acupuncture and MT treatments using a visual analog scale about their perceived levels of pain, stress, nausea, and neuropathy. The staff integrative clinicians collected data from patients, and post-treatment data were compiled by the Department of Integrative Medicine. Settings/Location: Aurora Cancer Centers are embedded within Aurora hospitals or free-standing clinics located throughout Wisconsin. In 2018, 15 cancer clinic locations embedded Mts, and 11 cancer clinic locations embedded Ats. Subjects: Oncology patients. Interventions: Clinical competencies were developed and applied to address indications, contraindications, and oncology-specific procedures to ensure that consistent quality of therapies was provided across sites. In 2018, Ats delivered 4367 Ats across 11 locations and Mts delivered 4197 Mts across 15 locations. During this study, the number of treatments provided was tracked versus episodic care. Outcome Measures: Pre/post AT and MT pain, stress, nausea, and neuropathy scores were recorded (0 [least] to 10 [worst]) and compared using paired t-tests. Results: Pre/post AT scores for pain, neuropathy, stress, and nausea were all significantly different (p < 0.001). For AT, there was a reported decrease in pain, stress, and neuropathy of 61.7%, 68.8%, and 47.9%, respectively. Pre/post MT scores for pain, neuropathy, nausea, and stress were also significantly different (p < 0.001). MT was greater at reducing stress and pain, 42.5% and 34.4%, respectively. Conclusions: Across 15 cancer clinics, both AT and MT treatments consistently and significantly reduced cancer-related side effects. These findings highlight the value of conducting a larger randomized-controlled trial to further assess the impact of Oncological Multisite Massage and Acupuncture Therapy on cancer-related symptoms across multiple oncologic clinics.

Data on prior pegylated liposomal doxorubicin (PLD) treatment in recurrent ovarian cancer: Post-hoc data analysis from the phase 3 randomized, open-label study comparing trabectedin and PLD versus PLD alone in patients with recurrent ovarian cancer.

The data presented herein are supplementary to our published primary article "A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer"[1]. The exploratory analysis evaluated the impact of prior pegylated liposomal doxorubicin (PLD) therapy in patients who participated in a randomized, open-label study comparing combination therapy of trabectedin and PLD vs PLD alone in third-line recurrent ovarian cancer (ROC). These exploratory analyses showed that prior treatment with PLD in ROC does not impact the response and survival rates nor does it increase toxicities or negatively influence survival and response rates in both treatment groups.

A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer.

OBJECTIVE: This phase 3 study aimed to compare overall survival (OS) of women with platinum-sensitive, recurrent ovarian cancer (ROC) treated with third-line trabectedin (T) + pegylated liposomal doxorubicin (PLD) vs. PLD monotherapy. METHODS: Women with advanced-relapsed epithelial ovarian cancer were randomly assigned 1: 1 to intravenous infusions of either T + PLD (trabectedin 1.1 mg/m2 for 3 h; PLD 30 mg/m2 for 1.5 h, every 3 weeks) or PLD (50 mg/m2 for 1.5 h, every 4 weeks). Primary endpoint was OS. Secondary endpoints included investigator-assessed progression free survival (PFS) and objective response rates (ORR). At randomization, patients were stratified by time from last dose of first-line platinum therapy to disease progression, ECOG grade 0 or 1, BRCA1/2 germline mutational status, and prior PLD therapy. Exploratory endpoints included OS, PFS, and ORR in the stratified subgroups (PFI, ECOG, BRCA1/2 status, and prior PLD therapy). This trial is registered with ClinicalTrials.gov, number NCT01846611. RESULTS: 576 patients were randomized (T + PLD, n = 289; PLD, n = 287). Median OS was 23.8 months with T + PLD vs. 22.2 months with PLD (HR:0.92, 95%CI:0.73-1.18; p = 0.52). Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01). Patients with BRCA1/2 mutations had median OS of 34.2 months with T + PLD vs. 20.9 months with PLD (HR:0.54, 95%CI:0.33-0.90; p = 0.016). Patients with BRCA1/2 mutations had median PFS of 10.1 months with T + PLD vs. 7.6 months with PLD (HR:0.72, 95%CI:0.48-1.08; p = 0.039). Patients with BRCA1/2 mutations and a 6-12 months platinum-free interval (PFI), median OS was 31.5 vs. 14.9 months, respectively (HR:0.37, 95%CI:0.17-0.82; p = 0.011). Grade 3-4 AEs were higher in T + PLD (79%) vs. PLD (54%). CONCLUSION: Combination of T and PLD did not show favorable OS benefit nor safety; however, patients with germline BRCA1/2 mutations and/or a PFI of 6-12 months appear to have clinically relevant survival benefit with T + PLD. No new safety signals were identified.

Phase 1b Study of Abiraterone Acetate Plus Prednisone and Docetaxel in Patients with Metastatic Castration-resistant Prostate Cancer.

Coadministration of docetaxel and abiraterone acetate plus prednisone (AA + P) may benefit patients with metastatic castration-resistant prostate cancer (mCRPC) because of complementary mechanisms of action. COU-AA-206 was a phase 1b study to determine the safe dose combination of docetaxel and AA + P in three cohorts of chemotherapy-naïve mCRPC patients. Twenty-two patients received escalating doses of docetaxel plus AA + P. The primary endpoint was the proportion of patients with a dose-limiting toxicity (DLT) between weeks 2 and 7. The recommended phase 2 dose (RP2D) was the highest safe combination of docetaxel plus AA + P. Prostate-specific antigen (PSA) changes and intensive pharmacokinetic parameters for each drug were evaluated. Docetaxel 75mg/m2 + AA 1000mg + P 10mg was deemed the RP2D, with DLT in one of six patients. PSA declines from baseline of ≥50% and ≥90% were observed for 85.7% and 66.7% of patients, respectively. During median follow-up of 14.5 mo, eight patients had PSA progression and six had radiographic progression or died. Systemic exposure was comparable for docetaxel and abiraterone when given alone or in combination. Studies are ongoing to confirm the efficacy of potent androgen receptor-targeted therapy plus taxane in early mCRPC. PATIENT SUMMARY: The combination of hormonal therapy and chemotherapy may improve outcomes in men with metastatic prostate cancer. This study demonstrates the ability to combine the hormonal therapy agent abiraterone acetate, plus prednisone, and the chemotherapy drug docetaxel with an acceptable side effect profile. A high rate of prostate-specific antigen decline was seen, but the study was small and additional research is needed before this becomes a standard approach.