Impact of objective response (OR) on patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 (gBRCA) mutation in the phase III EMBRACA trial

133 Background: Specialty palliative care (SPC) has been shown to improve quality of life, reduce unnecessary health care utilization, reduce overall costs, and decrease mortality in some settings for patients with advanced or metastatic cancer, however only a small proportion are being promptly referred. As interventions that respond to patient reported outcomes (PROs) have been shown to improve symptoms and decrease mortality, we hypothesized that the rates of SPC referral would be increased by documenting, tracking, and presenting PROs for oncology visits to referring oncologists. Methods: Over a period of 2 months, 74 English-speaking established patients seen in an advanced breast cancer clinic with an embedded SPC service were approached and completed the study. All patients filled out the electronic, validated PROMIS and PRO-CTCAE PRO questionnaires in the waiting room using a touch screen tablet. Results were presented to the oncologist during the encounter if the CTCAE severity score exceeded 3 in at least 1 domain. Patient demographics, clinical features and PC referrals or appointments were assessed via chart review. Results: At baseline, 9 (12.2%) patients scored a minimum of “severe” (4/5 or 5/5) in at least 1 of the 3 anxiety domains; 17 (23.0%) had moderate-severe pain; and 27 (32.1%) reported fatigue. At study entry, 25 patients (33.8%) had been referred previously to the SPC service; 19 had actually been seen (76% of referred). Of the 63 (85.1%) patients with sufficient follow-up, 13 (20.6%) reported at least “severe” in >1 CTCAE domains, 6 (46.2%) of whom were previously referred to SPC. For the remaining 7 patients, median PROMIS T-score and PRO-CTCAE maximum severity score were 58.3 and 3.2, respectively; none were referred to SPC during the follow up period. Conclusions: The choice to refer (or not to refer) a patient to SPC is complex and tied to patient specific factors such as coordinating additional visits and fear of end of life conversations. To enable greater access to SPC, alternative referral mechanisms, such as group-based or personalized patient education, or automatic referrals triggered by evidence of need, may be required. #YRL/CDM contributed equally.

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A Randomized Trial of Chemotherapy with or without Estrogenic Recruitment in Locally Advanced Breast Cancer

Tumori Journal ◽

10.1177/030089169708300511 ◽

1997 ◽

Vol 83 (5) ◽

pp. 829-833 ◽

Cited By ~ 5

Author(s):

Editta Baldini ◽

Giovanni Gardin ◽

Piergiorgio Giannessi ◽

Fulvio Brema ◽

Alessandra Camorriano ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Locally Advanced Breast Cancer ◽

Objective Response ◽

Locally Advanced ◽

Dose Intensity ◽

Advanced Breast ◽

Phase Iii ◽

Pathologic Features ◽

Significant Difference

The present phase III trial was carried out to verify whether a kinetic recruitment induced by low doses of diethylstilbes-trol (DES) could increase the killing efficacy of chemotherapy in patients with locally advanced breast cancer. One-hundred and seventeen untreated patients with locally advanced breast cancer (stage IIIA/IIIB) were randomized to receive 3 courses of primary chemotherapy consisting of cyclophosphamide (600 mg/m2 i.v.), doxorubicin (50 mg/m2 i.v.) and fluorouracil (600 mg/m2 i.v.) (CAF) on day 1, or DES-CAF (DES, 1 mg orally days 1-3, CAF on day 4). The courses were repeated every 3 weeks. The patients who achieved an objective response were submitted to mastectomy followed by 3 courses of CAF alternated with 3 courses of CMF (cyclophosphamide, 600 mg/m2 i.v.; methotrexate, 40 mg/m2 i.v.; fluorouracil, 600 mg/m2 i.v.), with or without DES. The two treatment arms were well balanced in terms of clinical and pathologic features. There was no significant difference in response rates to induction chemotherapy between the two treatment arms (objective response rate, 63.3% for CAF and 56.1% for DES-CAF). Median overall survival was 49 and 47 months and median progression-free survival was 24 and 21 months for CAF and DES-CAF patients, respectively. Toxicity was not significantly different in the two groups, with the exception of leukopenia: DES chemotherapy was significantly more myelotoxic than the standard treatment, which resulted in a significant reduction in the actual dose intensity. In spite of the attractive experimental evidence, we conclude that so far there is no clinical advantage in the combination of estrogen and chemotherapy. Further research is needed to investigate different schedules of chemotherapy and hor-mones, or to test the possibility of combining various mitogens.

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