bluuebunny/crossref_metadata_2025_split huggingface dataset:
Erlotinib as maintenance therapy after concurrent chemoradiotherapy in patients (p) with stage III non-small cell lung cancer (NSCLC): A Galician Lung Cancer Group phase II study
Authors: Casal J. , Vázquez S. , León L. , Lázaro M. , Fírvida J. L. , Amenedo M. , Alonso G. , Santomé L. , Afonso F. J. 
Published: August 2020

7537 Background: Combination of platinum-based chemotherapy and radiotherapy is the standard treatment for p with unresectable stage III NSCLC, but considering the high rates of recurrence, it is necessary to improve these results. Erlotinib is an EGFR TKI that prolongs survival in p with recurrent and metastatic NSCLC. In this study, we aim to evaluate the role of erlotinib as maintenance therapy after a standard concurrent chemo-radiotherapy regimen in p with stage III NSCLC. Methods: P with unresectable stage IIIA/IIIB—without malignant effusions—NSCLC who had received a standard concurrent chemo-radiotherapy regimen and had no evidence of tumor progression were enrolled in this single arm, open-label phase II study and received erlotinib 150 mg/day po for 6 months. Main eligibility criteria were: PS 0–2, adequate bone marrow, hepatic and renal function and measurable disease by RECIST criteria. Primary endpoint was the percentage of p without evidence of disease progression after 6 months of erlotinib therapy and secondary endpoints were: PFS, OS, ORR and safety profile. Results: 49 p have been included in the study and data from 37 p are presented in this analysis. Baseline characteristics: median age 62 years (range 41–76); male 94.6%; caucasian 100%; smokers/never smokers (%) 97.3/2.7; ECOG PS 0/1/2 (%) 18.9/75.7/2.7; adenocarcinoma/squamous cell carcinoma/large cell carcinoma (%) 16.2/75.7/5.4; stage IIIA/IIIB (%) 16.2/83.8. Most common previous chemo-radiotherapy regimen is cisplatin/docetaxel/RT (83.8%). 27 p were evaluable for tumor response: CR 22.2%; PR 12.8%; SD 55.6%; PD 7.4%. Median TTP was 7.3 months (95% CI 5.8–16.9) and median OS was 18.7 months (95% CI 11.8-NA). Most common adverse events related to erlotinib were rash 30.6% (3 p gr. 3) and diarrhea 16.7%. Conclusions: Erlotinib as maintenance therapy is an active and well tolerated treatment after concurrent chemo- radiotherapy in p with stage III NSCLC. In spite of the majority of patients are caucasian, males, smokers with squamous cell carcinoma, maintenance with single agent erlotinib reached a promising median OS of 18.7 months. Updated data will be presented. No significant financial relationships to disclose.
A multinational phase III randomized trial with or without consolidation chemotherapy using docetaxel and cisplatin after concurrent chemoradiation in inoperable stage III non-small cell lung cancer (CCheIN): Interim analysis
Authors: Park K. , Ahn Y. , Chen M. , Cho E. , Kim J. , Min Y. , Kim H. , Zhu G. , Heo D. S. , Wu Y. 
Published: August 2020

7538 Background: Currently, the recommended treatment for inoperable stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy (CCRT). The efficacy of consolidation chemotherapy after CCRT needs to be confirmed. The aim of this phase III randomized trial is to determine the efficacy of consolidation chemotherapy with docetaxel (D) and cisplatin (P) following definitive CCRT with the same agents in stage III inoperable NSCLC. Herein we report the pre-planned interim analysis. Methods: Patients with inoperable stage III NSCLC were randomized to either CCRT alone (observation arm) or CCRT followed by consolidation chemotherapy (consolidation arm). N2 or N3 disease was confirmed by PET and/or pathology. CCRT with D (20 mg/m2) and P (20 mg/m2) was administered every week for 6 weeks with a total dose of 66 Gy of thoracic RT as 33 fractions. In the consolidation arm, patients were further treated with 3 cycles of D and P (35 mg/m2 each on day 1 and 8, every 3 weeks). The primary endpoint is time to progression (TTP). Total target number of patients is 458. Results: From Oct 2005 to Mar 2008, 233 patients were enrolled and 226 were randomized (observation 112; consolidation 114). Patients’ characteristics were similar in both arms. In the consolidation arm, 83 patients (73%) received consolidation chemotherapy, of whom 52 (45%) completed 3 planned cycles. Grade 3–4 neutropenia occurred in 5.4% of 203 consolidation cycles. Common non-hematologic toxicities of all grades during consolidation were anorexia (47%), nausea (37%), vomiting (16%), fatigue (35%) and esophagitis (31%). At the time of this analysis, there were 40 and 41 deaths in the observation and consolidation arms, respectively. Treatment-related mortality rates were similar. With a median follow-up of 28.2 months, the median TTP was 9.0 months in the observation arm and 13.9 months in the consolidation arm (P=0.19). Median overall survival was 20.7 and 21.2 months, respectively (P=0.49). Conclusions: This interim analysis suggests that consolidation chemotherapy with DP after CCRT with weekly DP is feasible and relatively well tolerated. Patient enrollment is ongoing. No significant financial relationships to disclose.
A fractionated schedule of oral vinorelbine (NVBo) with cisplatin (CDDP) concomitantly with radiotherapy (RT) after induction chemotherapy (CT) in locally advanced (LA) non-small cell lung cancer (NSCLC): Safety and efficacy results of a phase II trial
Authors: Lerouge D. , Gervais R. , Dansin E. , Dujon C. , Chouaid C. , Riviere A. , Precheur-Agulhon B. , Piolat V. , Zalcman G. , Lartigau E. 
Published: August 2020

7539 Background: NVB+CDDP as induction and concomitant regimen with RT is a recognized treatment in LA NSCLC (Vokes, J Clin Oncol. 2002). The oral formulation of NVB may simplify the administration and a new fractionated schedule may further improve the results during CT-RT. Methods: Non operable stage IIIA-IIIB NSCLC patients (pts) received an induction CT of 2 cycles of NVBiv 25 mg/m2 + CDDP 80 mg/m2 on D1 and NVBo 60mg/m2 on D8 every 3 weeks. Non progressive pts received 2 additional cycles of fixed dose NVBo of 20 mg on D1, D3 and D5, + CDDP 80 mg/m2 on D1 every 3 weeks, combined with a conformal RT at 66 Gy. Results: Between October 05 and May 08, 70 pts were enrolled (68 evaluable for the safety, 64 for response) : 28% stage IIIA, 72% IIIB; 44 % squamous, 30 % adenocarcinoma; 85% male; median age 61 years (range 41;73); median KPS 90%. After induction CT, OR was 42% (PR), Disease Control (DC) = 87%. 4 pts were down-staged and underwent surgery. After CT-RT completion, OR was 55% (CR = 7%), DC = 88%. Main Toxicities (G3–4, % of pts) were: neutropenia (19%), N/V (1%), radic pneumopathy (1%), anorexia (7%). Oesophagitis was recorded in 42% of pts with no G3–4 : G1 (26%), G2 (16%). Conclusions: This new schedule provides a disease control in 88% of pts with 55% OR. Given the optimal tolerance profile of this fractionated administration of NVBo+CDDP, 72% of pts could complete the planned treatment. Furthermore, NVBo taken at home at D3 and D5 reduces the organizational constraints linked to CT-RT. This new scheme offers a well tolerated and efficient therapeutic option in the treatment of non operable IIIA-IIIB NSCLC. Further follow-up is required in order to assess time to progression and survival. [Table: see text]
Pulmonary functional map on V/Q SPECT and TGFβ1 during radiotherapy and post-treatment lung function in patients with non-small cell lung cancer
Authors: Yuan S. , Frey K. A. , Gross M. D. , Ramnath N. , Ten Haken R. K. , Cai X. , Hayman J. A. , Kong F. 
Published: August 2020

7543 Background: Current research focus on the TGFß1 and pulmonary perfusion (Q) SPECT pre or post-treatment to predict lung toxicity in patients with non-small-cell lung cancer (NSCLC). However, ventilation (V) is also important, while the change of V/Q SPECT map and TGFβ1 during radiotherapy (RT) maybe more predictive for the lung function post-treatment. Methods: Patients with stage I-III NSCLC undergoing radiation based treatment were included and V/Q SPECT-CT, circulating TGF ß1 and carbon monoxide diffusing capacity (DLCO), as the key parameter of pulmonary function test, were assessed pre-, during- and 3 months post-RT. Patients were treated with conformal radiation therapy of more than 60 Gy, with or without chemotherapy per standard of care based on their stage of disease. The defects of V/Q SPECT images were defined by semi-quantitive method. Results: Total 45 patients with stage I-III NSCLC undergoing radiation (>60 Gy) were enrolled. All patients had functional defects (V, or Q or both) at or adjacent to the tumor and the V/Q defects were mismatched in 40%, 50% and 23% patients, pre-, during- and post-RT, respectively. After 45 Gy, the V and Q defects improved remarkably in 38.4% and 34.6% patients respectively, and the V scores were also improved significant during-RT (p<0.01). The Q scores of ipsilateral lung and V score of both lungs during-RT were correlated with DLCO 3 months post-RT margin-significantly (p=0.07) and significantly (p=0.02). The TGFß1 level decreased significantly during-RT and TGFß1 ratios (over the pre-RT level) at 4- and 6-week during-RT correlated with DLCO 3 months post-RT significantly (p=0.05). Conclusions: The V/Q SPECT map and TGFß1 level change during RT, and these changes are predictive for the lung function post-treatment in patients with NSCLC. No significant financial relationships to disclose.
Impact of positron emission tomography (PET) in stage III non-small cell lung cancer (NSCLC): A prospective randomized trial (PET START)
Authors: Ung Y. , Sun A. , MacRae R. , Gu C. , Wright J. , Yu E. , Darling G. , Leighl N. , Evans W. , Levine M. 
Published: August 2020

7548 Background: Patients with stage III NSCLC are potentially curable using combined modality therapy (CMT) with chemotherapy and radical radiation (RT). The use of PET-CT rather than conventional imaging (CI) may better identify patients for CMT by enhanced tumor staging and improved definition of RT treatment volumes. Methods: Patients with stage III NSCLC (based on histology/cytology, brain CT/MRI, CT thorax, CT/US abdomen, and bone scan) who were considered candidates for CMT were randomized to either PET-CT or CT for RT treatment planning. The primary outcome was the proportion of patients who did not receive CMT because their tumor was upstaged to Stage 4 or their intrathoracic tumor was too extensive for radical RT. Overall survival (OS) and alteration of RT treatment planning volume were secondary outcomes. Target sample size was 400 patients based on a hazard rate reduction of 30% in OS at 2 years in favor of PET-CT with 2-sided alpha = 0.05 and 80% power. We also postulated that 200 patients would be required to detect a 20% difference between arms for the primary endpoint. 5 centers in Ontario participated. Results: The trial commenced in August 2004. In November 2008 after a planned interim analysis for the primary outcome, the Data Safety Monitoring Board recommended stopping recruitment because of superior efficacy with PET-CT. 304 patients were randomized and 289 had analyzable data. 25 patients were unsuitable for CMT: 21 in the PET-CT arm (16 upstaged to Stage 4 and 5 unsuitable for radical RT) and 4 in the CT arm (unsuitable for radical RT). Thus, 21 of 140 (15%) patients in the PET-CT arm achieved the primary outcome compared with 4 of 149 (2.7%) in the CT arm, P= 0.0002. Conclusions: This is the first randomized trial in stage III NSCLC showing that PET-CT is superior to CT planning alone in selecting appropriate patients for CMT. Longer patient follow-up will determine potential impact on OS. No significant financial relationships to disclose.
Chemoradiation therapy in patients (pts) with small cell lung cancer (SCLC) with pericardial effusion but no distant metastasis
Authors: Niho S. , Kubota K. , Yoh K. , Goto K. , Ohmatsu H. , Saijo N. , Nishiwaki Y. 
Published: August 2020

7555 Background: Our previous retrospective analysis demonstrated that the survival of the limited-disease (LD) SCLC pts with ipsilateral pleural effusion was intermediate between those of LD pts without ipsilateral pleural effusion and extensive-disease (ED) pts, and that long-term survival was achieved by LD-SCLC pts with ipsilateral pleural effusion who successfully underwent chemoradiotherapy (CRT) (J Thorac Oncol 2008;3:723–7). We retrospectively investigated the clinical course and outcome in pts with SCLC with pericardial effusion but no distant metastasis and examined the overall survival in pts who received chemotherapy and definitive thoracic radiotherapy (TRT). Methods: The medical records of SCLC pts who received treatment at the National Cancer Center Hospital East between July 1992 and December 2007 were reviewed. During this period 767 pts were newly diagnosed as having SCLC. Four-hundred seventeen pts had no distant metastasis. Ninety-six of those 417 pts (23%, 95% confidence interval (CI): 19–27%) had pleural or pericardial effusion or disseminated pleural nodules, and were included in this study. The 96 pts were divided into two groups: group A included pts with pericardial effusion (n=33), and group B included pts who had pleural effusion and/or disseminated pleural nodules, but did not have pericardial effusion (n=63). Sixteen pts had both pleural and pericardial effusion. Results: All but one patient received systemic chemotherapy. A remaining patient with pleural effusion received only best supportive care. In group A, 19 pts received chemoradiotherapy. TRT was conducted concurrently with 3 or 4 cycles of chemotherapy in 12 pts and sequentially in 7 pts. The response rate for first-line chemotherapy was 79%. In group B, 26 pts received chemoradiotherapy. Survival data were shown as below. Conclusions: Long-term survival was seldom achieved by SCLC pts with pericardial effusion but no distant metastasis, even if they underwent chemoradiotherapy. [Table: see text] No significant financial relationships to disclose.
Phase III study of induction chemotherapy (docetaxel and carboplatin) with or without radiotherapy followed by surgery in patients with stage IIIA (pN2) non-small cell lung cancer (NSCLC): WJTOG9903
Authors: Tada H. , Tanaka M. , Katakami N. , Kurata T. , Mitsudomi T. , Negoro S. , Kudoh S. , Nishiyama H. , Nishimura Y. , Nakagawa K. 
Published: August 2020

7556 Background: Standard treatment of resectable N2 disease is not yet established. To gain insights on significance of preoperative chemoradiotherapy, we tried to evaluate feasibility and efficacy of induction chemotherapy with or without radiotherapy followed by surgery in patients with stage IIIA NSCLC with mediastinal lymph node metastases. Methods: Patients with histologically proven N2 disease were randomized either to receive induction chemotherapy (taxotere 60 mg/m2 and carboplatin AUC 5x2 cycles) with concurrent radiation therapy of 40Gy/20fr (CRS group) or without it (CS group). Patients subsequently underwent pulmonary resection if the tumor was judged resectable. Original sample size was 180 to detect a 20% of survival difference (2 sided P=0.05) with a power of 0.8. The primary endpoint was overall survival. Results: Between Jan. 2001 and Dec 2005, 60 patients were randomized Because of poor accrual of the patients, the study was prematurely terminated. Two patients assigned to CRS group were ineligible due to staging misconducts. Median age was 57 years (range 34–70 years), and 66% were male. Two groups were well balanced with regard to age, gender, histology, and operative procedures. Induction therapy was well tolerated, and there was no treatment related death. Grade 3 and 4 neutropenia occurred in 74 and 89%, respectively. Objective response rate was 25% for the both groups. Surgical resection was performed in 86% and 89%of the patients in CS and CRS groups, respectively. There have been 37 deaths to date. Event free survival at 3 year was 18% and 32% for patients in CS and CRS group, respectively (HR=0.64; 95% CI: 0.36–1.17, P=0.15). Overall survival at 3 year was 44.4 %. and 52.7% (HR=0.84; 95% CI: 0.44–1.62, P=0.62), respectively. Conclusions: Because of small sample size, there was no statistically significant difference. However, our study suggested that addition of radiotherapy to induction chemotherapy could potentially prolong survival of NSCLC patients with N2 disease. [Table: see text]
Response, time to progression, and overall survival of patients with stage III lung cancer in a minority-based cohort
Authors: Kouz R. , Sreenivasappa S. , Adab K. , Ciobanu B. , Ofori S. , Shah M. , Kassem M. , Hussein L. , Lad T. 
Published: August 2020

7558 Background: Lung cancer is the leading cause of cancer death. Response and survival of patients (pts) with stage III lung cancer in minority population is not well studied. Methods: 79 pts treated between 2001 and 2006 were studied as a retrospective cohort. Clinical and survival data were analyzed using fisher's test, chi square test, Kaplan Meier analyses. Results: 33 Pts had Stage IIIA; Median age at diagnosis was 58 yrs (37–75). 14 were males (42.4%) 19 females (57.6%) 26 African American (78.8%) and 7 Caucasians (21.2%). Median number of co morbidities 2 (0–4). Mean follow up was 25 months (mo) (2 - 93), 19 had surgery (12 Lobectomy (36.4%), 7 Pneumonectomy (21.2%)) and 14 were unresectable (42.4%). All pts received adjuvant chemotherapy. Unresectable pts received chemotherapy and radiation, 8 carboplatin and gemcitabine and 6 cisplatin and etoposide. Median time to progression in resectable IIIA was 23 mo (2- 67), unresectable IIIA was 12 mo (3–93). Median survival in pts with resection was 26 mo (2 - 67), unresectable was 12 mo (5 - 93). Overall survival and time to progression was not influenced by sex, race, tumor type. 46 pts had stage IIIB, median age at diagnosis 57.5 yrs (40–68). 31 were males (67.4%) 15 females (32.6%) 29 African Americans (63%) 11 Caucasians (23.9) 3 Asians (6.5%) and 3 Hispanics (6.5%). Median follow up was 10 mo (3–97). All pts received chemotherapy and radiation. 23 received cisplatin and etoposide (50%), 14 carboplatin and gemcitabine (30%), 5 carboplatin and etoposide (9%), 5 carboplatin and paclitaxel (9%). 13 had complete response (28.3%), 15 partial response (32.6%), 2 stable disease (4.3%) and 10 Progression (21.7%). Median time to progression was 9 mo (3–97). Median overall survival was 10 mo (3–97). Overall survival and time to progression was not influenced by sex, race, tumor type, chemotherapy regimen. Conclusions: In this minority based cohort response, time to progression, overall survival in both IIIA and IIIB pts is much lower then historical controls. The overall survival and time to progression in both IIIA and IIIB is not influenced by race, sex, tumor type and type of chemotherapy regimen. Further investigations of disease and healthcare disparities in the underserved minority population, are warranted. No significant financial relationships to disclose.
Adjuvant chemotherapy in completely resected stage III-N2 non-small cell lung cancer
Authors: Wang S. , Ou W. , Sun H. , Yang H. , Ye X. , Fang Q. 
Published: August 2020

7563 Background: We evaluate effect of postoperative adjuvant chemotherapy on overall survival after complete resection of stage III-N2 non-small-cell lung cancer. Methods: From Jan.1999 to Dec. 2003, a total of 150 stage III-N2 non-small cell lung cancer patients randomly received four cycles of chemotherapy (NVB25mg/m2, D1,D5 or paclitaxel 175mg/m2, D1 / carboplatin AUC=5, D1) or observation after operation. Results: The median survival for the 150 patients was 879 days, with a 1-year survival rate of 81%, 3-year survival rate of 43%, and 5-year survival rate of 28%.There was significant difference in median survival between chemotherapy and control group (897 days vs 821 days p=0.04), and also there was significant difference in 5-year survival rate (30% vs 24% p<0.05). The most common site of recurrence was brain. 26% (39/150) of patients recurred in the brain as their first site, 22% (18/79) for chemotherapy group, 29% (21/71) for control group. The median survival time for brain metastasis patients between chemotherapy and control group is no difference (812 days vs 512 days, p=0.122), but there was significant difference in 2-year survival rate (66.71% vs 37.6% p<0.05). Conclusions: Postoperative adjuvant chemotherapy dose significantly improves median survival among completely resected stage III-N2 non-small-cell lung cancer patients, and significantly improves 5-year survival rate. It dose not decrease incidence of brain metastasis but postpone the time of brain metastasis in chemotherapy group. No significant financial relationships to disclose.
Impact of revised lymph node measurement rules in the new RECIST version 1.1 on the tumor response evaluation in patients with advanced lung cancer
Authors: Endo M. , Watanabe H. , Yamamoto S. , Yamamoto N. , Ohe Y. , Tamura T. 
Published: August 2020

7567 Background: The new RECIST ver. 1.1 was published in a special edition of the European Journal of Cancer in the first quarter of 2009 (EJC 2009;45:228). The major change involves the rules for lymph node measurement, which is to measure SHORT axis in stead of the longest diameter of lymph node. To be considered pathologically enlarged and measurable, a size of lymph node must be at least 15mm in short axis when assessed by CT scan. Lymph nodes that are at least 10mm but less than 15mm in short axis may be pathologic and can be considered as non-measurable/non-target lesions (not measured). The purpose of our study was to evaluate the response assessment using RECIST ver. 1.1. in comparison with that using ver. 1.0 in patients with advanced lung cancer. Methods: Two radiologists independently reviewed the objective tumour response of 305 patients (pts) with advanced lung cancer who had primary lesion and lymph node metastases as target lesions measured more than 10 mm in the longest diameter. According to ver. 1.1, only the short axis will be measured both at baseline and at follow-up. The response rates were calculated according to both the versions of RECIST. The tumor responses were divided into four categories (CR, PR, SD, PD), following proportion of agreement and estimation of kappa statistics between two the criteria as agreement measure. Results: The best overall responses as assessed by RECIST ver. 1.0 and ver. 1.1 are shown in the table. Out of the 108 pts with PR by ver.1.0, 8.3 % were downgraded to SD and 1.0 % was categorized as PD by ver.1.1. On the other hand, out of the 190 pts with SD by ver.1.0, 6.3 % were upgraded to PR and 8.9 % were downgraded to PD by ver.1.1. The proportion of agreement was 86.2 % (263/305, 95% CI: 75.8 - 96.6) and the kappa coefficient was 0.734 (95% CI: 0.662 - 0.806). Conclusions: No significant impact was observed for the revised lymph node measurement rules in the new RECIST ver. 1.1 on the response evaluation in pts with advanced lung cancer registered in this analysis. [Table: see text] [Table: see text]