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Paclitaxel and trastuzumab for small HER2-positive breast cancers
Although combinations of multiple chemotherapy agents plus the anti-HER2 agent trastuzumab are appropriate for many HER2-positive breast cancers, single agent paclitaxel plus trastuzumab (TH) has been investigated for smaller cancers. In longer term followup of a previously reported observational study of over 400 patients with node-negative, HER2-positive breast cancers <=3 cm, TH was associated with seven year overall and disease free survival rates of 95 and 93 percent, respectively [1,2]. Although we typically use trastuzumab plus multiple chemotherapy agents for HER2-positive breast cancers that are either node-positive or >2 cm, these data support our approach of using TH for smaller, node-negative HER2-positive breast cancers.
Extended versus standard pelvic lymph node dissection in radical cystectomy
In observational studies of patients with bladder cancer undergoing radical cystectomy, extended pelvic lymph node dissection (PLND) has been associated with improved oncologic outcomes compared with standard PLND (bilateral pelvic lymphadenectomy). In the first randomized trial comparing the two approaches in over 400 patients with cT1-4aN0M0 urothelial carcinoma, extended PLND resulted in nonsignificant trends toward higher recurrence-free survival, cancer-specific survival, and overall survival at five years [3]. Limitations included low statistical power and exclusion of patients receiving neoadjuvant chemotherapy. Longer follow-up data and results from a second ongoing trial will help to inform decision-making about the optimal extent of PLND at radical cystectomy.
Pexidartinib in relapsed tenosynovial giant cell tumors
Tenosynovial giant cell tumor (TGCT) is a rare, non-lethal soft tissue tumor caused by translocation-induced macrophage overexpression of the CSF1R gene. Although patients are treated with initial surgery, postoperative relapse is common, resulting in severe functional limitations and poor quality of life. In a randomized phase III trial of over 100 patients with relapsed unresectable TGCT, the CSF1R inhibitor pexidartinib improved functional outcomes and response rates (39 versus 0 percent) relative to placebo, but also increased grade >=3 hepatotoxicity (10 versus 0 percent) [4]. These data led to approval of pexidartinib by the US Food and Drug Administration (FDA) for TGCT not amenable to surgery [5]. We use it in this setting, but monitor liver biochemical tests prior to and during treatment.
FOLFOX after progression on gemcitabine plus cisplatin for advanced biliary tract cancer
The optimal second-line chemotherapy regimen for patients with advanced biliary tract cancer (BTC) who progress on first-line gemcitabine plus cisplatin (Gem/Cis) is not established. In the randomized ABC-06 trial, which directly compared short-term infusional fluorouracil plus leucovorin and oxaliplatin (FOLFOX) with active symptom control alone in patients progressing after first-line Gem/Cis, FOLFOX improved overall survival at 6 (61 versus 36 percent) and 12 months (26 versus 11 percent) [6]. Grade 3 or 4 toxic events were more frequent in the chemotherapy group, especially neutropenia and fatigue. For most patients with advanced BTC who have disease progression while receiving Gem/Cis and who retain an adequate performance status, we suggest second-line FOLFOX.
Vasectomy and risk of prostate cancer
Whether a prior vasectomy increases risk for prostate cancer is controversial. In a population-based study of over two million Danish men born between 1937 and 1966, prior vasectomy was associated with a 15 percent higher risk for prostate cancer that persisted for at least 30 years after the procedure [7]. Observational studies, however, do not prove a causal relationship between vasectomy and prostate cancer, as confounding factors cannot be excluded in the selection of men who underwent the procedure. Some physicians performing vasectomy choose to discuss the small potential risk for prostate cancer in the interest of full disclosure; however, we continue to follow the 2015 guidelines of the American Urological Association, which state that clinicians do not need to routinely discuss prostate cancer in pre-vasectomy counseling [8].
1. Tolaney SM, Barry WT, Dang CT, et al. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med 2015; 372:134.
2. Tolaney SM, Guo H, Pernas S, et al. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Clin Oncol 2019; 37:1868.
3. Gschwend JE, Heck MM, Lehmann J, et al. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol 2019; 75:604.
4. Tap WD, Gelderblom H, Palmerini E, et al. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet 2019; 394:478.
5. https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-r (Accessed on August 04, 2019).
6. Lamarca A, Palmer DH, Wasan HS, et al. ABC-06 | A randomised phase III, multi-centre, open-label study of Active Symptom Control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy. J Clin Oncol 37, 2019 (suppl; abstr 4003). Abstract available online at https://meetinglibrary.asco.org/record/173183/abstract (Accessed on June 25, 2019).
7. Husby A, Wohlfahrt J, Melbye M. Vasectomy and prostate cancer risk: a 38-year nationwide cohort study. J Natl Cancer Inst 2019.
8. https://www.auanet.org/guidelines/vasectomy-(2012-amended-2015) (Accessed on June 13, 2017).
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