Bajpai Jyoti, Abraham George, Saklani Avanish P, Agarwal Anshul, Das Sashanka, Chatterjee Ambarish, Kapoor Akhil, Eaga Prathyusha, Mondal Pradip Kumar, Chandrasekharan Arun, Bhargava Prabhat Ghanshyam, Srinivas Sujay, Turkar Siddharth, Rekhi Bharat, Khanna Nehal, Janu Amit Kumar, Bal Munita, Ostwal Vikas Sureshchand, Ramaswamy Anant, Rohila Jitender, Desouza Ashwin L, Guha Amrita, Kumar Rajiv, Menon Nandini Sharrel, Rath Sushmita, Patil Vijay Maruti, Noronha Vanita Maria, Joshi Amit Prakashchandra, Laskar Siddhartha, Rangarajan Venkatesh, Prabhash Kumar, Gupta Sudeep, Banavali Shripad
Department of Medical Oncology, Tata Memorial Hospital, Homibhabha National Institute, Mumbai, India.
Department of Surgical Oncology, Tata Memorial Hospital, Homibhabha National Institute, Mumbai, India.
Front Oncol. 2021 Sep 8;11:710585. doi: 10.3389/fonc.2021.710585. eCollection 2021.
Treatment of malignant melanoma has undergone a paradigm shift with the advent of immune checkpoint inhibitors (ICI) and targeted therapies. However, access to ICI is limited in low-middle income countries (LMICs).
Histologically confirmed malignant melanoma cases registered from 2013 to 2019 were analysed for pattern of care, safety, and efficacy of systemic therapies (ST).
There were 659 patients with a median age of 53 (range 44-63) years; 58.9% were males; 55.2% were mucosal melanomas. Most common primary sites were extremities (36.6%) and anorectum (31.4%). Nearly 10.8% of the metastatic cohort were BRAF mutated. Among 368 non-metastatic patients (172 prior treated, 185 de novo, and 11 unresectable), with a median follow-up of 26 months (0-83 months), median EFS and OS were 29.5 (95% CI: 22-40) and 33.3 (95% CI: 29.5-41.2) months, respectively. In the metastatic cohort, with a median follow up of 24 (0-85) months, the median EFS for BSC was 3.1 (95% CI 1.9-4.8) months versus 3.98 (95% CI 3.2-4.7) months with any ST (HR: 0.69, 95% CI: 0.52-0.92; P = 0.011). The median OS was 3.9 (95% CI 3.3-6.4) months for BSC alone versus 12.0 (95% CI 10.5-15.1) months in any ST (HR: 0.38, 95% CI: 0.28-0.50; P < 0.001). The disease control rate was 51.55%. Commonest grade 3-4 toxicity was anemia with chemotherapy (9.5%) and ICI (8.8%). In multivariate analysis, any ST received had a better prognostic impact in the metastatic cohort.
Large real-world data reflects the treatment patterns adopted in LMIC for melanomas and poor access to expensive, standard of care therapies. Other systemic therapies provide meaningful clinical benefit and are worth exploring especially when the standard therapies are challenging to administer.
随着免疫检查点抑制剂(ICI)和靶向治疗的出现,恶性黑色素瘤的治疗发生了范式转变。然而,中低收入国家(LMICs)获得ICI的机会有限。
分析2013年至2019年登记的组织学确诊的恶性黑色素瘤病例的治疗模式、全身治疗(ST)的安全性和疗效。
共有659例患者,中位年龄53岁(范围44 - 63岁);58.9%为男性;55.2%为黏膜黑色素瘤。最常见的原发部位是四肢(36.6%)和直肠肛管(31.4%)。近10.8%的转移队列患者存在BRAF突变。在368例非转移患者中(172例曾接受过治疗,185例初治,11例不可切除),中位随访26个月(0 - 83个月),中位无进展生存期(EFS)和总生存期(OS)分别为29.5个月(95%置信区间:22 - 40)和33.3个月(95%置信区间:29.5 - 41.2)。在转移队列中,中位随访24个月(0 - 85个月),最佳支持治疗(BSC)的中位EFS为3.1个月(95%置信区间1.9 - 4.8),而任何全身治疗(ST)为3.98个月(95%置信区间3.2 - 4.7)(风险比:0.69,95%置信区间:0.52 - 0.92;P = 0.011)。单纯BSC的中位OS为3.9个月(95%置信区间3.3 - 6.4),而任何ST为12.0个月(95%置信区间10.5 - 15.1)(风险比:0.38,95%置信区间:0.28 - 0.50;P < 0.001)。疾病控制率为51.55%。最常见的3 - 4级毒性反应是化疗引起的贫血(9.5%)和ICI引起的贫血(8.8%)。多因素分析显示,在转移队列中接受任何ST均有更好的预后影响。
大量真实世界数据反映了中低收入国家黑色素瘤的治疗模式以及难以获得昂贵的标准治疗方案。其他全身治疗提供了有意义的临床益处,尤其在标准治疗难以实施时,值得探索。