Abstract P4-12-05: A retrospective study of 27 patients with ER-positive, HER2 negative metastatic breast cancer treated with concomitant palbociclib and radiation therapy

Author(s):  
Arnaud Beddok ◽  
Alexandre Arsene-Henry ◽  
Baptiste Porte ◽  
Kim Cao ◽  
Louis Bazire ◽  
...  
2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13039-e13039
Author(s):  
Coral Olazagasti ◽  
Wingsze Liu ◽  
Chung-Shien Lee ◽  
Taylor Decina ◽  
Karalyn Pappas ◽  
...  

e13039 Background: Since 2015, CDK4/6 inhibitors (CDKi) have become part of standard of care in the treatment ER-positive, Her2Neu negative of metastatic breast cancer (MBC). Hematologic toxicity from CDKi are common. Pooled analysis of prior randomized trials did not show hematologic toxicity between younger and older adult age groups. We sought to review generalizability of these findings to our community population. Methods: We conducted a retrospective single institution retrospective study on patients who were treated with CDKi from 2015 to 2019. Patients were stratified according to age > 70 years and < 69 years. Data from absolute neutrophil count, hemoglobin and platelet count on Days 1 and 15 of the first 2 cycles were graded for hematologic toxicity according to CTCAE v 5.0. Our primary objective was to assess any difference in grade of hematologic toxicities in the different age groups. Our secondary objective was to analyze the association between hematologic toxicities with the presence or absence of bone metastasis and/or prior chemotherapy exposure. Results: A total of 220 patients were reviewed, 140 were < 69 years and 80 > 70 years. There was no significant effect of time (p = 0.91) with respect to the outcome of hematologic toxicity adjusting for age (p = 0.16). Seventy-seven percent (171/220) of patients had evidence of bone marrow (BM) involvement. There was no significant difference in the grade of any hematologic toxicities over time (p = 0.97) and underlying BM disease (p = 0.20). On the other hand, 50% (111/220) patients had previously received an average of one line of chemotherapy. There was significant positive correlation between lines of therapy and grade of neutropenia (rS= 0.25, p = 0.0028). Overall, the estimated median progression free survival (PFS) was 19.1 months. The median overall survival could not be estimated. Conclusions: Our single institution experience does not show significant hematologic toxicity between patient age groups nor evidence of bone metastasis. However, prior exposure to chemotherapy can have a significant effect in the grade of neutropenia. Our study revealed that there is no difference in PFS according to dosing or age which correlates with current literature.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12598-e12598
Author(s):  
Arnaud Beddok ◽  
Alexandre Arsene-Henry ◽  
Baptiste Porte ◽  
Kim Cao ◽  
Nathaniel Scher ◽  
...  

e12598 Background: Palbociclib, a small-molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), combined with letrozole increases progression-free survival among patients with previously untreated ER-positive, HER2 negative advanced breast cancer. The purpose of our study was to retrospectively evaluate the tolerance of the concomitant association of Palbociclib and radiation therapy (RT) at Curie Institute. Methods: Between April 2017 and August 2019, 30 women with ER-positive, HER2 negative metastatic breast cancer received locoregional (LR) and/or symptomatic irradiation at a metastatic site concurrently with Palbociclib at a daily dose of 125 mg, from d1 to d21 every 28 days. Palbociclib was always associated with endocrine therapy: letrozole (with or without an LHRH analogue) or fulvestrant. Thirty-five sites were irradiated: nine patients received post-operative locoregional RT, including the chest wall or breast and lymph node areas, and 26 sites of metastases were irradiated: 17 at the spine, 7 peripheral skeletal lesions, 1 brain lesion and 1 choroidal lesion. The dose prescribed for locoregional mammary radiotherapy was 50 Gy in 25 fractions and varied for the treatment of metastatic sites: 20 Gy in 5 fractions (n = 13), 30 Gy in 10 fractions (n = 10) and 8 Gy in 1 fraction (n = 2). The brain metastasis was stereotactically treated (1 fraction of 18 Gy). The primary endpoint was toxicity scored according to the common terminology criteria for NCI adverse events, version v5.0. Results: Mean number of days of Palbociclib during RT was 8.8 days (range, 1 to 24 days). The most common acute toxicities were dermatitis (12/35, including 2 grade 2) and neutropenia (12/35, including 9 grade 2). Palbociclib had to be stopped during the RT of two patients (2/30): one patient treated locoregionally (bilateral breast and lymph nodes irradiation) developed a grade 3 dermatitis and febrile neutropenia, another treated locoregionally developed grade 2 dysphagia. After a median follow-up since the end of RT of 17 months (6 – 31 months, SD 8), none of the patients have so far exhibited late toxicity. Conclusions: Concomitant administration of palbociclib with RT was reasonably well tolerated in our series of 30 patients. Given this experience, palbociclib should not be discontinued during radiation therapy. Nevertheless, our findings should be confirmed in prospective registration studies collecting larger number of patients.


2021 ◽  
Vol 32 ◽  
pp. S73
Author(s):  
C. Saavedra Serrano ◽  
B. Pérez Mies ◽  
M. Gion Cortes ◽  
A. Cortes Salgado ◽  
M. Fernández Abad ◽  
...  

1993 ◽  
Vol 11 (3) ◽  
pp. 474-477 ◽  
Author(s):  
M A Cobleigh ◽  
K Dowlatshahi ◽  
T A Deutsch ◽  
R G Mehta ◽  
R C Moon ◽  
...  

PURPOSE Considerable attention has been focused on the chemopreventive properties of fenretinide against carcinogen-induced rodent mammary cancer. Less is known about its direct antitumor effects. The combination of tamoxifen and fenretinide is more effective than tamoxifen or fenretinide alone in prevention of rat mammary cancer. However, the combined toxicity of tamoxifen plus fenretinide in humans is unknown. Therefore, we performed a phase I/II trial in women with estrogen receptor (ER)-positive or progesterone receptor (PR)-positive, previously untreated metastatic breast cancer. PATIENTS AND METHODS Groups of three patients received tamoxifen 20 mg/d, or tamoxifen plus fenretinide 100, 200, 300, or 400 mg/d. Patients who received fenretinide enjoyed a 3-day "drug holiday" every 4 weeks. Serum levels of fenretinide and its major metabolites were monitored. Patients were monitored for known toxicities of tamoxifen and vitamin A analogs, as well as for response. RESULTS There were no significant adverse effects on renal, hepatic, hematologic, or lipid values. Nyctalopia, photophobia, cheilitis, and pruritus were not observed. Improvement or stabilization of disease occurred in 12 of 15 patients. CONCLUSION We conclude that tamoxifen administered with fenretinide is nontoxic. Phase III trials of tamoxifen versus tamoxifen plus fenretinide are warranted.


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