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Adjuvant abemaciclib in high-risk, hormone receptor-positive, HER2-negative breast cancer (October 2021)

For patients with high-risk, hormone receptor (HR)-positive, HER2-negative breast cancer, previous data have shown benefits with adjuvant abemaciclib. Now, in longer follow-up of 27 months, benefits are maintained, both in regard to invasive disease-free survival (three-year rate of 89 versus 83 percent), and distant recurrence-free survival (90 versus 86 percent) [1]. A higher incidence of Grade >=3 adverse events (AEs) was observed with versus without abemaciclib (50 versus 16 percent, respectively). These data led to US Food and Drug Administration approval of abemaciclib in patients with HR-positive, HER2-negative, node-positive breast cancer at high risk of recurrence and a Ki-67 score >=20 percent [2], and we suggest the addition of adjuvant abemaciclib to endocrine therapy in this subset. High risk in this instance is defined as either >=4 involved axillary lymph nodes; or 1 to 3 involved lymph nodes and either tumor grade 3 or tumor grade >=5.0 cm. However, we note that it is also acceptable not to administer this additional treatment, given the toxicity and only short-term supporting data.


Long-term survival in patients with pediatric adrenocortical carcinoma (November 2021)

For pediatric patients with adrenocortical carcinoma (ACC), there are limited data for the long-term prognosis of this rare disease. A prospective, single-arm study of approximately 80 pediatric patients with ACC described the outcomes of stage I patients treated with adrenalectomy; stage II patients treated with adrenalectomy and retroperitoneal lymph node dissection; and stage III or IV patients treated with mitotane and chemotherapy, followed by surgery as clinically indicated [3]. Five-year overall survival rates, according to stage, were 95 percent for stage I; 79 percent for stage II; 95 percent for stage III; and 16 percent for stage IV disease. Although patients with stage III disease had better outcomes relative to those with stage II disease, potentially due to receipt of mitotane and chemotherapy, we consider multiple factors (eg, grade, extent of vascular invasion) in decisions regarding systemic therapy.


Pembrolizumab as initial therapy for metastatic urothelial carcinoma (November 2021)

The United States (US) Food and Drug Administration (FDA) previously conditionally approved the checkpoint inhibitor pembrolizumab for patients with treatment-naive metastatic urothelial carcinoma (UC), but long-term follow-up data were limited. In extended follow-up of a phase II trial of almost 400 patients with treatment-naive, platinum-ineligible metastatic UC, the objective response rate for pembrolizumab was 29 percent at a median follow-up of 56 months, and three-year overall survival was 22 percent [4]. Based on these data, the US FDA granted full regulatory approval to pembrolizumab for patients with locally advanced or metastatic UC who are not eligible for any platinum-containing chemotherapy [5], and it remains one of our preferred options in this patient population.


Adjuvant immunotherapy in resectable NSCLC (July 2021, Modified November 2021)

The role of immunotherapy in resectable non-small cell lung cancer (NSCLC) was previously undefined. In a randomized trial in almost 900 patients with stage II to IIIA NSCLC who had undergone surgery and adjuvant chemotherapy, those randomly assigned to atezolizumab had improved disease-free survival relative to the best supportive care group (42 versus 35 months, hazard ratio [HR] 0.79), with greater benefits among those with tumor PD-L1 >=1 percent (not evaluable versus 35 months; HR 0.66) [6]. Based on these data, atezolizumab is approved by the US Food and Drug administration (FDA) as adjuvant treatment following resection and platinum-based chemotherapy for adults with stage II to IIIA NSCLC whose tumors have programmed cell death ligand 1 (PD-L1) expression on >=1 percent of tumor cells, as determined by an FDA-approved test [7].


1. Harbeck N, Rastogi P, Martin M, et al. Adjuvant Abemaciclib Combined With Endocrine Therapy for High-Risk Early Breast Cancer: Updated Efficacy and Ki-67 Analysis From the monarchE Study.


2. Ann Oncol. 2021; PMID: 34656740.


3. Abemaciclib tablets. United States Prescribing Information. US National Library of Medicine. (Accessed on October 15, 2021).


4. Rodriguez-Galindo C, Krailo MD, Pinto EM, et al. Treatment of Pediatric Adrenocortical Carcinoma With Surgery, Retroperitoneal Lymph Node Dissection, and Chemotherapy: The Children's Oncology Group ARAR0332 Protocol. J Clin Oncol. 2021;39(22):2463. Epub 2021 Apr 6.


4. O'Donnell PH, Balar AJ, Vuky J, et al. First-line pembrolizumab (pembro) in cisplatin-ineligible patients with advanced urothelial cancer (UC): Response and survival results up to five years from the KEYNOTE-052 phase 2 study. J Clin Oncol. 2021;39;15S.


5. Pembrolizumab: United States Food and Drug Administration Prescribing Label,s118lbl.pdf (Accessed on September 07, 2021).


6. Felip E, Altorki N, Zhou C, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398(10308):1344. Epub 2021 Sep 20.


7. Atezolizumab injection. United States Prescribing Information. US National Library of Medicine. (Accessed on October 27, 2021).


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