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Ribociclib plus endocrine therapy in aggressive hormone receptor-positive, HER2-negative metastatic breast cancer (January 2023)

For hormone receptor-positive, HER2-negative metastatic breast cancer, initial treatment often consists of endocrine therapy plus a cyclin-dependent kinase 4/6 inhibitor (CDK 4/6i), but chemotherapy has been favored for extensive visceral metastases. Now, in a trial in 222 premenopausal patients with aggressive, hormone receptor-positive, HER2-negative breast cancer (half of whom had visceral crises), initial treatment with endocrine therapy plus ribociclib improved progression-free survival relative to combination chemotherapy (24 versus 12 months), with better tolerability.¹ Time to tumor response was 4.9 versus 3.2 months, respectively. For patients with hormone receptor-positive, HER2-negative metastatic breast cancer, including those with extensive visceral metastases, we typically suggest endocrine therapy plus a CDK 4/6i, although chemotherapy is an appropriate alternative.

Perioperative versus adjuvant gemcitabine and nabpaclitaxel for resectable pancreatic cancer (January 2023)

For patients with resectable pancreatic adenocarcinoma, clinical trials are evaluating the role of neoadjuvant versus adjuvant chemotherapy. In a randomized phase II trial (NEONAX) in over 100 patients with resectable pancreatic cancer, 6 months of perioperative (two cycles of neoadjuvant and four cycles of adjuvant) gemcitabine plus nabpaclitaxel was compared with 6 months of adjuvant treatment with the same chemotherapy.² Median disease-free survival was 12 versus 6 months for perioperative versus adjuvant treatment, and median overall survival was 26 versus 17 months, respectively, but these differences were not statistically significant. For patients with potentially resectable pancreatic cancer, we consider either 6 months of perioperative systemic chemotherapy or adjuvant chemotherapy to be appropriate strategies. If perioperative chemotherapy is chosen, gemcitabine plus nabpaclitaxel is an appropriate option for the adjuvant component of treatment.

Lack of survival benefit for atezolizumab as initial therapy in advanced urothelial carcinoma (January 2023)

Atezolizumab, a programmed cell death ligand-1 (PD-L1) inhibitor, was previously approved by the US Food and Drug Administration (FDA) for patients with advanced or metastatic urothelial carcinoma (mUC) in patients ineligible for any platinum-based chemotherapy and in those with PD-L1 positive cancers ineligible for cisplatin-based chemotherapy. However, in a randomized phase III trial of over 1000 patients with treatment-naive mUC, the addition of atezolizumab to platinum-based chemotherapy failed to improve overall survival.³ Based on these data, the FDA withdrew regulatory approval for atezolizumab for the above indications, and we no longer use it as initial therapy for patients with platinum-ineligible mUC.⁴

Direct oral anticoagulants for treatment of venous thromboembolism in patients with brain tumors (January 2023)

Accumulating evidence in patients with brain tumors suggests that direct oral anticoagulants (DOACs) are associated with a lower risk of intracranial hemorrhage (ICH) than other forms of anticoagulation. In a recent observational study of 121 patients with glioblastoma and venous thromboembolism (VTE) who were treated with a DOAC or low molecular weight (LMW) heparin, the six-month incidence of clinically relevant ICH was lower with DOACs than LMW heparin (0 versus 24 percent), while rates of recurrent VTE were similar (0 versus 4 percent).⁵ Based on these and other data, we favor DOACs as a safer and more convenient option in patients with primary and metastatic brain tumors who are selected to receive anticoagulation for VTE. We generally avoid anticoagulation in patients with intratumoral hemorrhage within the past four weeks or a remote history of a clinically significant ICH.

1. Lu YS, Mahidin E, Azim H, et al. GS1-10 Primary results from the randomized Phase II RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2-advanced breast cancer treated with ribociclib + endocrine therapy vs physician's choice combination chemotherapy. SABCS. 2022.

2. Ettrich TJ, Berger AW, Perkhofer L, et al. Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group. BMC Cancer. 2018;18(1):1298. Epub 2018 Dec 29.

3. Galsky MD, Arija JAA, Bamias A, et al. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10236):1547.

4. Atezolizumab: US Food and Drug Administration Prescribing Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s050lbl.pdf (Accessed on December 08, 2022).

5. Reed-Guy L, Desai AS, Phillips RE, et al. Risk of intracranial hemorrhage with direct oral anticoagulants vs low molecular weight heparin in glioblastoma: A retrospective cohort study. Neuro Oncol. 2022;24(12):2172.

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