Editor’s Note: The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, one of the world’s most influential oncology conferences, was held in Chicago from May 30 to June 3. This year, a study led by Dr. Hongbing Liu from the Second Affiliated Hospital of Nanjing Medical University, in collaboration with the Jinling Clinical Medical College team, was selected for poster presentation (Abstract #8548). The research, titled "Camrelizumab Combined with Two-Cycle Chemotherapy as First-Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC): A Dual-Arm, Single-Center, Phase II Study", addresses a critical clinical question: Can the duration of chemotherapy be safely reduced? The study offers important insights for personalized treatment strategies in elderly NSCLC patients. Below is an in-depth discussion with Dr. Liu on the key findings.Clinical Background: Balancing Efficacy and Tolerability
In recent years, immune checkpoint inhibitors (PD-1/PD-L1) combined with chemotherapy have become the first-line standard for advanced NSCLC, showing superior efficacy compared to chemotherapy alone. However, in real-world clinical practice—particularly among elderly patients—the tolerance to the standard four-cycle platinum-based doublet chemotherapy is often poor due to frailty and multiple comorbidities. This raises an important clinical question: Can we reduce chemotherapy intensity without compromising efficacy?
To explore this, the team designed a prospective, dual-arm, single-center Phase II trial (Registration number: ChiCTR2200065078) comparing two versus four cycles of chemotherapy in combination with camrelizumab. The goal: to identify a safer, more accessible treatment regimen for elderly patients.
Study Design and Methods
The trial enrolled 40 patients with stage IIIB–IV NSCLC who had not received prior systemic treatment and had no EGFR/ALK driver mutations. Patients were randomized into two groups:
· Group A (n = 16): Two cycles of platinum-based chemotherapy plus camrelizumab
· Group B (n = 24): Four cycles of platinum-based chemotherapy plus camrelizumab
Following induction therapy, both groups continued with camrelizumab maintenance until disease progression or unacceptable toxicity, with a maximum treatment duration of two years.
· Primary Endpoint: Progression-Free Survival (PFS)
· Secondary Endpoints: Objective Response Rate (ORR), Overall Survival (OS), and Safety
Patient Characteristics: Elderly Patients Lean Toward Shorter Regimens
As of December 1, 2024, all 40 patients had been enrolled. Notably, the median age in Group A was significantly higher than in Group B (75.5 vs. 69.0 years; P = 0.001), suggesting that clinicians tend to offer reduced-intensity treatment to older patients. Apart from age, other baseline characteristics such as sex, cancer stage, smoking history, and histologic subtype were well balanced between the two groups.
Efficacy: Short-Cycle Regimen Shows Promise Despite Modestly Lower Outcomes
After a median follow-up of 17.6 months, the results were as follows:
· PFS: 5.4 months (Group A) vs. 13.0 months (Group B), P = 0.195
· ORR: 6.2% (Group A) vs. 41.7% (Group B), P = 0.036
· OS: 11.4 months (Group A) vs. 24.1 months (Group B), P = 0.079
Although Group A showed somewhat lower response rates and survival outcomes, the differences were not statistically significant for PFS or OS. This suggests that the two-cycle regimen may still be a viable option, particularly for elderly or frail patients who may not tolerate intensive treatment.
Safety Profile: Two-Cycle Group Demonstrates Lower Toxicity
· Any-grade Treatment-Related Adverse Events (TRAEs): 93.8% (Group A) vs. 100% (Group B)
· Grade ≥3 TRAEs: 6.2% (Group A) vs. 12.5% (Group B)
The most common hematologic toxicities included anemia, leukopenia, and neutropenia, while non-hematologic toxicities involved elevated liver enzymes, proteinuria, and hypoalbuminemia. Overall, the two-cycle group exhibited a milder toxicity profile, especially in terms of severe adverse events.
Expert Commentary: A Positive Step Toward Tailored Care for the Elderly
Dr. Hongbing Liu emphasized that lung cancer treatment is entering an era of “precision stratification,” where patient subgroups exhibit markedly different levels of treatment tolerance. For elderly or comorbid patients, a reduced-intensity approach—such as two cycles of chemotherapy combined with immunotherapy—may offer a favorable balance between efficacy and safety. While these findings warrant confirmation in larger, multicenter trials, they provide valuable preliminary data for refining treatment strategies.
Given that a significant proportion of lung cancer patients in China are elderly, personalized treatment approaches are crucial. This study offers a promising direction by exploring reduced chemotherapy duration, paving the way for more flexible first-line treatment options.
Looking ahead, further large-scale, real-world studies will be essential to determine how best to balance efficacy and toxicity across diverse patient populations—advancing the field from standardized to truly personalized cancer care.
About Dr. Hongbing Liu
· Director, Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Nanjing Medical University
· Chief Physician, Associate Professor, and Master’s Supervisor
· Visiting Scholar at the University of Colorado School of Medicine
· Member, Youth Committee, Chinese Society of Clinical Oncology (CSCO) Lung Cancer Group
· Member, CSCO Expert Panel on Tumor Biomarkers
· Member, Chest Tumor Precision Therapy Committee, Chinese Primary Health Care Foundation
· Member, Tumor Precision Diagnosis and Treatment Committee, Chinese Primary Health Care Foundation
· Deputy Leader, Tobacco Control Group, Jiangsu Medical Association Respiratory Society
· Member and Academic Secretary, Jiangsu Medical Association Respiratory Society
· Member, Lung Cancer and Interventional Group, Military Respiratory Medicine Society
· Member, Nanjing Medical Association Respiratory Society
· Member, Interventional Pulmonology Committee, Haixi Health Center
· Jiangsu Provincial “333” High-Level Talent
· Youth Talent, Jiangsu “Medical-Education Integration” Program
· Published over 80 SCI papers, with 40+ as first or corresponding author
· Principal investigator on multiple national and provincial research grants
· Recipient of the Jiangsu Science and Technology Progress First Prize, MOE Science and Technology Second Prize, and Jiangsu Medical Innovation Second Prize
· Editorial Board Member, Translational Lung Cancer Research
