Efficacy and Safety of Sintilimab Combined with Platinum-containing Double-agent Chemotherapy in First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Elderly Patients

Inclusion Criteria

• •1. Provided written informed consent before performing any trial-related procedures;
• •2. Age 60-80 years old;
• •3. Study participants with histologically or cytologically confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM stage), inoperable and definitive concurrent chemoradiotherapy without previous systemic therapy;
• •4. No EGFR gene sensitive mutation or ALK gene fusion mutation was confirmed by histological specimens; At least one radiographic measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
• •6\. Had not received any previous systemic antitumor therapy for advanced/metastatic disease. Participants who had received previous platinum-based adjuvant/neoadjuvant chemotherapy or definitive chemoradiotherapy for advanced disease were allowed if they had disease progression or relapse at least 6 months after the last dose of chemotherapy.
• •7\. Study participants with asymptomatic or symptomatic stable brain metastases after local treatment were allowed to enroll as long as the study participant met the following conditions:
• •1\) measurable lesions outside the central nervous system 2) no central nervous system symptoms or worsening of symptoms for at least 2 weeks 3) no glucocorticoid treatment was required, glucocorticoid treatment was discontinued within 7 days before the first dose, or the glucocorticoid dose was stable and reduced to less than 10mg/ day prednisone (or equivalent) within 7 days before the first dose 8. Study participants were allowed to receive palliative radiation therapy 7 days before the first dose of study drug and with a return of radiotherapy-related toxicity to grade 1 or less (CTCAE5.0); 9.ECOG score 0-2; 10. Expected survival time \>3 months; 11. Adequate organ function, study participants had to meet the following laboratory measures:
• •1. absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days;
• •2. platelet count ≥100×109/L without blood transfusion in the past 14 days;
• •3. hemoglobin \>9g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days;
• •4. Total bilirubin ≤1.5 times upper limit of normal value (ULN)
• •5. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 ×ULN (participants with liver metastases were allowed ALT or AST ≤5×ULN);
• •6. serum creatinine ≤1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
• •7. good coagulation function, defined as INR or PT ≤1.5 times ULN;
• •9. Myocardial enzymes within the normal range (isolated laboratory abnormalities that were judged by the investigators as not clinically significant were also allowed).
• •12\. Study participants were discretionary in applying the study regimen.
• •1. HBV viral load \<1000 copies /ml (200 IU/ml) before the first dose, study participants should receive anti-HBV therapy throughout the study chemotherapy to avoid viral reactivation
• •2. Study participants with anti-HBc (+), HBsAg (-), anti-hbs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy, but close monitoring for viral reactivation is required 12. Active HCV-infected study participants with positive HCV antibodies and HCV-RNA levels above the lower limit of detection; 13. A live vaccine dose within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed.
• •14\. The presence of any serious or uncontrolled systemic illness, such as:
• •1. significant rhythm, conduction or morphological abnormalities in resting ECG, such as complete left bundle branch block, ≥ Ⅱ degree heart block, ventricular arrhythmia or atrial fibrillation;
• •2. unstable angina, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
• •3. myocardial infarction within 6 months before enrollment;
• •4. poor blood pressure control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
• •5. patients had a history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose of glucocorticoid, or current clinically active interstitial lung disease;
• •6. active pulmonary tuberculosis;
• •7. presence of active or uncontrolled infection requiring systemic therapy;
• •8. presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
• •9. liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
• •10. poorly controlled diabetes (fasting blood glucose (FBG) \> 10mmol/L);
• •11. Urine routine test showed urinary protein ≥++ and confirmed 24-hour urinary protein quantitation \> 1.0 g;
• •12. participants with a psychiatric disorder who were unable to cooperate with treatment; Any medical history or evidence of illness, abnormal treatment or laboratory values, or other conditions that might interfere with the results of the trial or prevent full participation in the study were considered by the investigators to be other potential risks that might preclude participation.