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  1. Ho KY, Ahn JS, Calimag MM, Chao TC, Kim YC, Moon H, et al.
    Asia Pac J Clin Oncol, 2018 Jun;14(3):159-166.
    PMID: 28670820 DOI: 10.1111/ajco.12696
    AIM: To examine the treatment practices for cancer pain relief and adverse event management, and the factors related to patient outcomes in the participating countries/regions.

    METHODS: The study was a cross-sectional survey conducted between September and December 2013 in 10 countries/regions across Asia. Adult patients with a history of cancer pain at least 1 month before study entry completed the survey questionnaire.

    RESULTS: A total of 1190 patients were included. The mean Box Scale-11 (BS-11) pain score was 6.0 (SD 2.1), with 86.2% experiencing moderate-to-severe pain and 53.2% receiving opioids at time of the survey. The mean BS-11 scores were 5.3 (SD 2.1) in the "others" (single non-opioid medication or untreated) group, 6.3 (SD 2.0) in the ≥2 non-opioids group and 6.7 (SD 1.9) in the opioid group. The proportions of patients experiencing moderate-to-severe pain were 79.1%, 87.3% and 93.7%, respectively. About 70% of patients reported adverse events due to their pain medications, about half had received medications to manage these symptoms. Adverse events were negatively associated with activities of daily living (P < 0.0001). Pain and hindrance to activities of daily living were negatively associated with employment status (P = 0.003 and 0.021). Unemployment was significantly associated with poorer quality of life (P < 0.0001).

    CONCLUSION: This analysis demonstrates inadequate management of cancer pain and treatment-related adverse events in the participating cohort. Pain and inadequate management of adverse events were negatively associated with patients' overall well-being. More collaborative efforts should be taken to optimize pain treatment and increase awareness of adverse event management in physicians.

  2. ACHEON Working Group, Kim YC, Ahn JS, Calimag MM, Chao TC, Ho KY, et al.
    Cancer Med, 2015 Aug;4(8):1196-204.
    PMID: 25914253 DOI: 10.1002/cam4.471
    In order to implement more effective policies for cancer pain management, a better understanding of current practices is needed. Physicians managing cancer pain and patients experiencing cancer pain were randomly surveyed across 10 Asian countries to assess attitudes and perceptions toward cancer pain management. A total of 463 physicians (77.3% oncologists) with a median experience of 13 years were included. Medical school training on opioid use was considered inadequate by 30.5% of physicians and 55.9% indicated ≤ 10 h of continuing medical education (CME). Of the 1190 patients included, 1026 reported moderate-to-severe pain (median duration, 12 months). Discordance was observed between physician and patient outcomes on pain assessment with 88.3% of physicians reporting pain quantification, while 49.5% of patients claimed that no scale was used. Inadequate assessment of pain was recognized as a barrier to therapy optimization by 49.7% of physicians. Additional barriers identified were patients' reluctance owing to fear of addiction (67.2%) and adverse events (65.0%), patients' reluctance to report pain (52.5%), excessive regulations (48.0%) and reluctance to prescribe opioids (42.8%). Opioid use was confirmed only in 53.2% (286/538) of patients remembering their medication. Pain affected the activities of daily living for 81.3% of patients. These findings highlight the need for better training and CME opportunities for cancer pain management in Asia. Collaborative efforts between physicians, patients, policy makers, and related parties may assist in overcoming the barriers identified. Addressing the opioid stigma and enhancing awareness is vital to improving current standards of patient care.
  3. O'Brien T, Ahn JS, Chye R, Le B, Lu H, Olarte G, et al.
    J Opioid Manag, 2019 7 26;15(2):147-158.
    PMID: 31343716 DOI: 10.5055/jom.2019.0496
    Transdermal buprenorphine (TDB) has demonstrated effectiveness in treating a range of chronic pain conditions, including cancer pain, nociceptive pain, and neuropathic pain and has a favorable safety profile. Worldwide, clinical experience of its use is relatively limited. There is considerable misunderstanding about the pharmacology, mechanism of action, and safety of buprenorphine. There is also limited guidance on the appropriate use of TDB for chronic pain management. This article presents an overview of TDB and also provides practical recommendations for its use as part of a multifaceted strategy in chronic cancer and non-cancer pain.
  4. Pivot X, Cortés J, Lüftner D, Lyman GH, Curigliano G, Bondarenko IM, et al.
    JAMA Netw Open, 2023 Apr 03;6(4):e235822.
    PMID: 37022687 DOI: 10.1001/jamanetworkopen.2023.5822
    IMPORTANCE: Trastuzumab has been the standard of care for the treatment of patients with ERBB2-positive breast cancer; however, cardiac events have been reported. This long-term follow-up study provides clinical evidence supporting the similarity of a trastuzumab biosimilar (SB3) to reference trastuzumab (TRZ).

    OBJECTIVE: To compare cardiac safety and efficacy between SB3 and TRZ for patients with ERBB2-positive early or locally advanced breast cancer after up to 6 years of follow-up.

    DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a randomized clinical trial, conducted from April 2016 to January 2021, included patients with ERBB2-positive early or locally advanced breast cancer from a multicenter double-blind, parallel-group, equivalence phase 3 randomized clinical trial of SB3 vs TRZ with concomitant neoadjuvant chemotherapy who completed neoadjuvant and adjuvant treatment.

    INTERVENTIONS: In the original trial, patients were randomized to either SB3 or TRZ with concomitant neoadjuvant chemotherapy for 8 cycles (4 cycles of docetaxel followed by 4 cycles of fluorouracil, epirubicin, and cyclophosphamide). After surgery, patients continued SB3 or TRZ monotherapy for 10 cycles of adjuvant treatment per previous treatment allocation. Following neoadjuvant and adjuvant treatment, patients were monitored for up to 5 years.

    MAIN OUTCOMES AND MEASURES: The primary outcomes were the incidence of symptomatic congestive heart failure and asymptomatic, significant decrease in left ventricular ejection fraction (LVEF). The secondary outcomes were event-free survival (EFS) and overall survival (OS).

    RESULTS: A total of 538 female patients were included (median age, 51 years [range, 22-65 years]). Baseline characteristics were comparable between the SB3 and TRZ groups. Cardiac safety was monitored for 367 patients (SB3, n = 186; TRZ, n = 181). Median follow-up was 68 months (range, 8.5-78.1 months). Asymptomatic, clinically significant LVEF decreases were rarely reported (SB3, 1 patient [0.4%]; TRZ, 2 [0.7%]). No patient experienced symptomatic cardiac failure or death due to a cardiovascular event. Survival was evaluated for the 367 patients in the cardiac safety cohort and an additional 171 patients enrolled after a protocol amendment (538 patients [SB3, n = 267; TRZ, n = 271]). No difference was observed in EFS or OS between treatment groups (EFS: hazard ratio [HR], 0.84; 95% CI, 0.58-1.20; P = .34; OS: HR, 0.61; 95% CI, 0.36-1.05; P = .07). Five-year EFS rates were 79.8% (95% CI, 74.8%-84.9%) in the SB3 group and 75.0% (95% CI, 69.7%-80.3%) in the TRZ group, and OS rates were 92.5% (95% CI, 89.2%-95.7%) in the SB3 group and 85.4% (95% CI, 81.0%-89.7%) in the TRZ group.

    CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, SB3 demonstrated cardiac safety and survival comparable to those of TRZ after up to 6 years of follow-up in patients with ERBB2-positive early or locally advanced breast cancer.

    TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02771795.

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