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Pembrolizumab plus chemotherapy in advanced triple negative breast cancer
In advanced triple negative breast cancer (TNBC), studies are evaluating the combination of immune checkpoint inhibitors with chemotherapy. In KEYNOTE 355, among almost 850 patients with advanced TNBC, the addition of pembrolizumab to chemotherapy improved progression-free survival (7.5 versus 5.6 months), particularly among those with Combined Positive Score (CPS) >=10 (9.7 versus 5.6 months) [1]. Based on these results, pembrolizumab is approved in combination with chemotherapy for patients with metastatic TNBC whose tumors express PD-L1 with a CPS >=10, and we consider it to be an acceptable option in this subset.
Celiac disease and risk of small bowel adenocarcinoma
Few studies have evaluated the risk of small bowel adenocarcinoma in patients with celiac disease. In a retrospective study that included approximately 48,000 individuals with celiac disease and 240,000 controls, the risk of small bowel adenomas and adenocarcinoma was increased in those with celiac disease (hazard ratio 5.73 and 3.05, respectively); however, the absolute risk of adenocarcinoma was low (5 per 10,000 celiac patients over 10 years) [2]. Individuals with celiac disease with mucosal healing had lower rates of small bowel adenocarcinoma than those with persistent villous atrophy (0.01 versus 0.18 percent), but the differences were not statistically significant. These data suggest that screening for small intestinal cancer in patients with celiac disease is not warranted.
New definition of deep submucosa invasion of malignant colonic polyps
Endoscopic resection of malignant colonic polyps is sufficient if they are completely resected en bloc and no high-risk features are present. For nonpedunculated polyps, deep submucosal invasion is a high-risk feature associated with lymph node metastasis. Because deep invasion has been defined as extending to the lower third of the submucosa (SM3) and the entire submucosa is typically not removed with endoscopic resection, this high-risk feature could not be evaluated adequately in some specimens. More recently, a more practical definition of deep invasion, >=1 mm into the submucosa as measured by an optical micrometer, has been adopted. We concur with this definition and the US Multi-Society Task Force on Colorectal Cancer (USMSTF) recommendation that nonpedunculated malignant colonic polyps with submucosal invasion depth >=1 mm should be considered for colon resection [3].
Gallium-68 PSMA-11 for PSMA-targeted PET imaging in prostate cancer
For men with prostate cancer, integrated positron emission tomography/computed tomography (PET/CT) imaging using a radiotracer targeting the prostate specific membrane antigen (PSMA) has better sensitivity and specificity for both pelvic lymph node and distant metastases over conventional imaging and other PET tracers. In December 2020, the US Food and Drug Administration approved Ga-68 PSMA-11 for PSMA-targeted PET imaging for men with prostate cancer who have a suspected recurrence based upon elevated PSA levels and for those with suspected metastases who are candidates for initial definitive therapy [4]. Where available, use of Ga-68 PSMA-11 is preferred over F-18 fluciclovine (Axumin) as a radiotracer for PET/CT.
Lorlatinib in treatment naive ALK-positive NSCLC
The next-generation ALK inhibitor lorlatinib is active in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) that has progressed on earlier generation ALK inhibitors, but its efficacy in treatment naive patients was previously unknown [5]. Now, in the randomized CROWN trial, among almost 300 treatment naive patients with advanced ALK-positive NSCLC, lorlatinib improved progression-free survival compared with crizotinib (not evaluable versus 9.3 months, hazard ratio 0.28). Among 30 patients with measurable brain metastases, the intracranial response rates were 82 versus 23 percent, respectively. However, pending overall survival data, we reserve lorlatinib for patients with advanced, ALK-positive NSCLC with progression on other ALK inhibitors.
1. Cortes J, Cescon DW, Rugo HS, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet 2020; 396:1817.
2. Emilsson L, Semrad C, Lebwohl B, et al. Risk of Small Bowel Adenocarcinoma, Adenomas, and Carcinoids in a Nationwide Cohort of Individuals With Celiac Disease. Gastroenterology 2020; 159:1686.
3. Shaukat A, Kaltenbach T, Dominitz JA, et al. Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps: Recommendations of the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2020; 159:1916.
4. FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targ (Accessed on December 02, 2020).
5. Shaw AT, Bauer TM, de Marinis F, et al. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med 2020; 383:2018.
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