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Ovarian function suppression for premenopausal patients with high risk hormone receptor positive, HER2-negative breast cancer (March 2023)
Premenopausal patients with high-risk hormone receptor-positive, HER2-negative breast cancer are often treated with ovarian function suppression (OFS) plus either an aromatase inhibitor (AI) or tamoxifen, but few data exist regarding the long-term benefits of OFS. At twelve years of follow-up of a randomized trial in premenopausal patients with hormone receptor-positive breast cancer, 85 percent of whom had HER2-negative disease, tamoxifen alone had a lower rate of disease-free survival (72 percent) relative to both tamoxifen plus OFS (76 percent) and exemestane plus OFS (79 percent).1 Overall survival rates were 87 percent with tamoxifen alone, 89 percent with tamoxifen plus OFS, and 89 percent with exemestane plus OFS. Given the toxicities associated with OFS, and the greater likelihood of benefit for those with high-risk features, we reserve its use for patients at high risk for recurrence from hormone receptor-positive, HER2-negative breast cancer (eg, those <=35 years of age or with risk factors for which chemotherapy is indicated).
Rucaparib in metastatic, BRCA-associated, castration-resistant prostate cancer (March 2023)
Trials are exploring the use of poly(ADP-ribose) polymerase inhibitors in metastatic, castration-resistant prostate cancer (CRPC) with certain genetic alterations. In a randomized trial, patients with CRPC with a BRCA1, BRCA2, or ATM alteration who had disease progression on a second-generation androgen-receptor pathway inhibitor (ARPI) were assigned to rucaparib or a physician's choice control.2 In the BRCA subgroup, the median duration of imaging-based, progression-free survival was longer with rucaparib than control (11.2 months versus 6.4 months). The most frequent adverse events with rucaparib were fatigue and nausea. For males with metastatic In the BRCA subgroup, the median duration of imaging-based, progression-free survival was longer with rucaparib than control (11.2 months versus 6.4 months). The most frequent adverse events with rucaparib were fatigue and nausea. For males with metastatic associated CRPC, we consider rucaparib to be an appropriate option after treatment with an ARPI and a taxane.
Reirradiation schedules for locally recurrent nasopharyngeal carcinoma (March 2023)
For patients with locally recurrent nasopharyngeal carcinoma (NPC), reirradiation using standard fractionation schedules poses therapeutic challenges, including a significant risk of late radiation (RT)-related complications. In an open-label randomized trial of almost 200 patients with locally recurrent, unresectable NPC, intensity-modulated RT (IMRT) using a hyperfractionated schedule (65 Gy in 54 fractions, given twice daily) improved three-year overall survival (75 versus 55 percent) and reduced grade >=3 toxicities (34 versus 57 percent) compared with standard fractionation (60 Gy in 27 fractions, given daily).3 Based on these data, for patients with locally recurrent unresectable NPC who are candidates for reirradiation, we administer IMRT using a hyperfractionated schedule rather than standard fractionation.
Nivolumab for advanced cutaneous squamous cell carcinoma (March 2023)
Studies are investigating immune checkpoint inhibitors for advanced cutaneous squamous cell carcinoma (cSCC). In a phase II trial of over 20 patients with metastatic and/or locally advanced cSCC treated with nivolumab, the objective response rate was 58 percent.4 Median progression-free and overall survival were 13 and 21 months, respectively. Nivolumab was also well tolerated even in older adults. Based on these data, we consider nivolumab to be one of several acceptable treatment options for patients with metastatic or locally advanced cSCC not amenable to treatment with surgery or radiation therapy.
1. Francis PA, Fleming GF, Lang I, et al. Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023;41(7):1370. Epub 2022 Dec 9.
2. Fizazi K, Piulats JM, Reaume MN, et al. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023;388(8):719. Epub 2023 Feb 16.
3. You R, Liu YP, Xie YL, et al. Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2023;401(10380):917. Epub 2023 Feb 23.
4. Munhoz RR, Nader-Marta G, de Camargo VP, et al. A phase 2 study of first-line nivolumab in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma. Cancer. 2022;128(24):4223. Epub 2022 Oct 24.
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