title: Three-Dimensional Radiation Therapy to the Primary Tumor With Concurrent Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer: Results of a Multicenter Phase 2 Study From PPRA-RTOG, China.
abstract: OBJECTIVE
  The aim of this prospective multi-institutional phase 2 study was to investigate disease control, survival outcomes, and toxicity after thoracic three-dimensional radiation therapy (3D-RT) with concurrent chemotherapy for newly diagnosed stage IV non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients were 18 to 80 years of age, had a Karnofsky performance status (KPS) score ≥70%, and newly diagnosed stage IV NSCLC with limited metastatic disease (defined as involving ≤3 organs). Patients received platinum-doublet chemotherapy with concurrent irradiation to the primary tumor. Primary endpoints were overall survival (OS) and acute toxicity.
  
  
  RESULTS
  From May 2008 to May 2012, 198 eligible patients were enrolled from 7 cancer centers. Most patients died with distant metastasis; only 10% died with isolated primary recurrence. Median OS time was 13.0 months (95% confidence interval [CI]: 11.7-14.3); OS rates were 53.5% at 1 year, 15.8% at 2 years, and 9.2% at 3 years. Median progression-free survival (PFS) time was 9.0 months (95% CI: 7.7-10.3); corresponding PFS rates were 30.8%, 8.2%, and 6.1%. The 1-year, 2-year, and 3-year local (primary tumor) control rates were 78.8%, 57.7%, and 55.4%. Multivariate analysis showed that delivery of ≥63 Gy to the primary tumor (P=.014), having a primary tumor volume <134 cm(3) (P=.008), and having a stable or higher KPS score after treatment (P=.01) were independent predictors of better OS. The most common severe (grades 3-4) acute toxicities were hematologic: leukopenia (37.9%), thrombocytopenia (10.1%), and anemia (6.9%). No patients experienced grade 4 or 5 radiation-related toxicity; 2.5% had acute grade 3 pneumonitis, and 6.6% had acute grade 3 radiation esophagitis.
  
  
  CONCLUSIONS
  Thoracic 3D-RT to the primary tumor with concurrent chemotherapy led to satisfactory survival outcomes with acceptable toxicity. Radiation dose, primary tumor volume, and PFS after treatment all predicted survival in these patients with limited-metastasis NSCLC.
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: ShengFa
authors.initials: S
authors.lastname: Su
authors.affiliation: Department of Radiation Oncology, Sichuan Cancer Hospital, Chengdu, PR China.
authors.forename: Tao
authors.initials: T
authors.lastname: Li
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China. Electronic address: lbgymaaaa@163.com.
authors.forename: Bing
authors.initials: B
authors.lastname: Lu
authors.affiliation: Department of Radiation Oncology, Gansu Cancer Hospital, Lanzhou, PR China. Electronic address: xhwanggansu@163.com.
authors.forename: XiaoHu
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou, PR China.
authors.forename: JianCheng
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, PR China.
authors.forename: Ming
authors.initials: M
authors.lastname: Chen
authors.affiliation: Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, PR China.
authors.forename: You
authors.initials: Y
authors.lastname: Lu
authors.affiliation: Department of Oncology, Affiliated Hospital of Zunyi Medical College, Zunyi, PR China.
authors.forename: YuJu
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: YinXiang
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: WeiWei
authors.initials: W
authors.lastname: Ouyang
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: Zhu
authors.initials: Z
authors.lastname: Ma
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: QingSong
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: HuiQin
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000209:etiology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D002681:China; D002945:Cisplatin / Q000008:administration & dosage; D016001:Confidence Intervals; D018572:Disease-Free Survival; D000077143:Docetaxel; D004941:Esophagitis / Q000209:etiology; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D007970:Leukopenia / Q000209:etiology; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D000068437:Pemetrexed / Q000008:administration & dosage; D011446:Prospective Studies; D017564:Radiation Pneumonitis / Q000209:etiology; D011878:Radiotherapy / Q000379:methods; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D013921:Thrombocytopenia / Q000209:etiology; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D055815:Young Adult
chemical_list: D043823:Taxoids; D000068437:Pemetrexed; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D002945:Cisplatin; D000077235:Vinorelbine