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No benefit with adjuvant ibandronate in postmenopausal women with breast cancer (September 2022)
For postmenopausal women with at least a moderate risk of breast cancer recurrence, adjuvant bisphosphonates have improved disease-free survival (DFS) outcomes in randomized trials. However, in a new randomized trial in over 1100 postmenopausal women, oral ibandronate 50 mg daily did not improve DFS relative to placebo [1,2]. Although a previous head-to-head trial that included both pre- and postmenopausal women found similar DFS outcomes with clodronate, ibandronate, and zoledronic acid, this trial is now the second in postmenopausal women to fail to show a DFS benefit from ibandronate over placebo. For patients in whom an adjuvant bisphosphonate is indicated for breast cancer, we suggest zoledronic acid or clodronate (algorithm 1), and consider ibandronate a less preferred alternative. Clodronate is not available in the United States.
First-line transarterial chemoembolization plus lenvatinib for advanced hepatocellular cancer (September 2022)
The optimal approach for patients with locally advanced unresectable hepatocellular cancer (HCC) is debated, especially in the setting of a large intrahepatic tumor burden or portal vein tumor thrombus (PVTT). In the Chinese phase III LAUNCH trial, which enrolled predominantly patients with hepatitis B-related HCC and advanced disease (PVTT, a large intrahepatic tumor burden, or extrahepatic spread), the combination of lenvatinib plus transarterial chemoembolization (TACE) improved survival and more than doubled the response rate compared with lenvatinib alone, but grade 3 or 4 adverse events were also more common [3]. Additional experience with lenvatinib plus TACE is needed in Western populations, where HCC is more often alcohol-related, before it can be concluded that this is a preferred approach over systemic therapy alone (especially immunotherapy-based approaches) for frontline therapy of advanced HCC.
Adjuvant pembrolizumab for resected renal cell carcinoma (September 2022)
In patients with localized clear cell renal cell carcinoma (RCC) treated with nephrectomy, adjuvant immunotherapy with pembrolizumab is an approved treatment option in the United States and Europe, but long-term studies on disease-free survival (DFS) are ongoing. In extended follow-up of a randomized trial (KEYNOTE-564) of approximately 1000 patients with clear cell RCC treated with nephrectomy, one year of adjuvant pembrolizumab continued to improve DFS compared with placebo (30-month DFS 75 versus 66 percent) and was well tolerated [4]. Based on these data, we continue to suggest adjuvant pembrolizumab for those with resected clear cell RCC who are at intermediate-high or high risk for disease recurrence following nephrectomy.
Pelvic intensity modulated radiation therapy in gynecologic cancers (August 2022)
Intensity modulated radiation therapy (IMRT) is an advanced form of radiation that changes the intensity of radiation in different parts of a single radiation beam. In a randomized trial of 289 patients with endometrial or cervical cancer receiving pelvic radiation, those in the IMRT arm experienced less high-level diarrhea compared with conventional radiation therapy at one year following radiation therapy (6 versus 15 percent) [5]. Moreover, at three years, patients in the IMRT arm experienced improvements in urinary function, while those in the conventional radiation arm reported a decline in function. These data add support for use of IMRT in gynecologic malignancies.
1. Vliek SB, Noordhoek I, Meershoek-Klein Kranenbarg E, et al. Daily Oral Ibandronate With Adjuvant Endocrine Therapy in Postmenopausal Women With Estrogen Receptor-Positive Breast Cancer (BOOG 2006-04): Randomized Phase III TEAM-IIB Trial. J Clin Oncol. 2022;40(25):2934. Epub 2022 Apr 20.
2. von Minckwitz G, Mobus V, Schneeweiss A, et al. German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer. J Clin Oncol. 2013;31(28):3531. Epub 2013 Aug 26.
3. Peng Z, Fan W, Zhu B, et al. Lenvatinib Combined With Transarterial Chemoembolization as First-Line Treatment for Advanced Hepatocellular Carcinoma: A Phase III, Randomized Clinical Trial (LAUNCH). J Clin Oncol. 2022
4. Powles T, Tomczak P, Park SH, et al. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022;23(9):1133.
5. Yeung AR, Deshmukh S, Klopp AH, et al. Intensity-Modulated Radiation Therapy Reduces Patient-Reported Chronic Toxicity Compared With Conventional Pelvic Radiation Therapy: Updated Results of a Phase III Trial. J Clin Oncol. 2022.
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