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Ribociclib plus fulvestrant in metastatic hormone receptor positive, HER2-negative breast cancer (August 2021)

For patients with metastatic hormone receptor-positive, HER2-negative breast cancer, fulvestrant plus the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib has shown progression-free survival benefits over fulvestrant alone in a randomized trial, but the effect on overall survival (OS) was not known. Now, in longer follow-up, the addition of ribociclib to fulvestrant improved OS (54 versus 42 months) [1]. Subgroup analyses were consistent in the first- and subsequent-line settings. We continue to recommend that a CDK 4/6 inhibitor be added for patients receiving fulvestrant for metastatic hormone receptor positive, HER2-negative breast cancer, provided they have not yet been treated with this class of agent.


Enfortumab vedotin for patients with metastatic urothelial carcinoma ineligible for cisplatin-based chemotherapy (August 2021)

Targeted therapies are an active area of investigation in patients with metastatic urothelial carcinoma who are ineligible for platinum-based chemotherapy and refractory to immunotherapy. In a phase II trial of almost 100 patients with locally advanced or metastatic disease ineligible for cisplatin and previously treated with immunotherapy, the targeted agent enfortumab vedotin demonstrated an objective response rate of 52 percent [2]. Based on these data, the US Food and Drug Administration granted regulatory approval to enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy and have previously received one or more prior lines of therapy [3]. In such patients, we offer either enfortumab vedotin or single-agent chemotherapy.


Updated version of the AJCC TNM staging for cervical cancer (August 2021)

An updated version of the American Joint Committee on Cancer (AJCC) tumor, node, metastasis (TNM) staging for cervical cancer was published in March 2021 and is available online [4]. This version is now in alignment with the 2018 International Federation of Gynecology and Obstetrics cervical cancer staging system (table 2). Both systems are acceptable staging systems and widely used.


Adjuvant capecitabine for locally advanced nasopharyngeal carcinoma (August 2021)

For patients with locoregionally advanced nasopharyngeal carcinoma (NPC) treated with chemoradiation, there is interest in identifying new adjuvant chemotherapy regimens that improve survival and have minimal toxicities. In a randomized phase III trial of over 400 patients with locoregionally advanced NPC, the addition of one year of adjuvant therapy with metronomic capecitabine to concurrent chemoradiation improved both three-year failure-free (85 versus 76 percent) and overall survival (93 versus 89 percent) and was well-tolerated, with high rates of treatment compliance [5] While promising, adjuvant capecitabine remains investigational, and we continue to suggest platinum-based chemotherapy in patients with locoregionally advanced NPC who receive adjuvant chemotherapy after chemoradiation.


Selection of central venous access device in patients with malignancy (August 2021)

Selecting the safest device for long-term central venous access is essential for patients with malignancy. The Cancer And Vascular Access (CAVA) randomized trial compared implanted port devices (PORTs), tunneled catheters (Hickman) and peripherally inserted central catheters (PICCs) in over 1000 patients receiving systemic anticancer therapy [6]. PORTs had a lower composite complication rate than either tunneled catheters or PICCs, which had similar complication rates. Differences in complications were driven mainly by higher infection rates for tunneled catheters and higher rates of thrombosis for PICCs. This trial confirms the outcomes of previous smaller trials and supports our recommendation for PORT placement in patients with malignancy who require long-term central venous access.


1. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021;32(8):1015. Epub 2021 Jun 5.


2. Yu EY, Petrylak DP, O'Donnell PH, et al. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):872. Epub 2021 May 12.


3. Enfortumab vedotin-ejfv for injection. United States Prescribing Information. US National Library of Medicine. (Accessed on July 12, 2021).


4. Olawaiye AB, Baker TP, Washington MK, et al. The new (Version 9) American Joint Committee on Cancer tumor, node, metastasis staging for cervical cancer. CA Cancer J Clin. 2021;71(4):287. Epub 2021 Mar 30.


5. Chen YP, Liu X, Zhou Q, et al. Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial. Lancet. 2021;398(10297):303. Epub 2021 Jun 7.


6. Moss JG, Wu O, Bodenham AR, et al. Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial. Lancet. 2021;398(10298):403. Epub 2021 Jul 21.


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