bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of hemoglobin level on the outcome of advanced non-small-cell lung cancer (NSCLC) treated with cisplatin and gemcitabine
Authors: Juan Vidal O. , Alberola V. , Muñoz J. , De Las Peñas R. , Camps C. , Massutí B. , Garcia Gómez R. , Provencio M. , Isla D. , Sánchez J. 
Published: March 2020

17010 Background: Negative impact of anemia on survival has been described in NSCLC patients (pts) treated with radiotherapy (RT) or concurrent radiochemotherapy, but scarcely data exist in NSCLC treated with chemotherapy (CT). PURPOUSE: To evaluate the prognosis value of baseline hemoglobin (Hb) among pts with advanced NSCLC treated with cisplatin and gemcitabine. Methods: 433 pts included in two trials conducted by the Spanish Lung Cancer Group (176 pts from the arm A of a randomized phase III trial comparing 3 regimens of CT and 257 pts from a phase II trial) were included in this analysis. No significant differences in baseline characteristics, response and survival (median 8.73 and 9.87 months, p=0.46) were observed between pts of the two trials. The baseline Hb and other potential risk factors for survival were analyzed with Cox Proportional Hazards model in an univariate an multivariate analysis. Results: Stage IIIB with positive pleural effusion (25%), stage IV (75%). 85% had ECOG PS 0–1. Median age: 60 years (range 31–82). 89% male. Histology: 41% adenocarcinoma, 39% squamous cell, 6.5% large cell, 14.5% NSCLC not otherwise specified. Median number of cycles received was 4 (range 1–8). Mean Hb level prior CT was 13.2 g/dl (range 8 to 19.6 g/dl). Response rate was 41% and median survival was 9.57 months (95% CI: 8.57–11–57). No statistically differences in survival were observed by stage (IIIB vs IV), age and gender. In the univariate analysis, number of cycles received (≤3 vs. >3 cycles), ECOG (2 vs 0–1), response (SD+PD vs CR+PR), baseline Hb (≤11 vs >11 gr/dl); minimum Hb during the CT (<10 vs ≥10) and second line CT (No vs Yes) emerged as prognostic factors for survival and were introduced in the multivariate model (see Table ). Conclusions: Hb level at the initiation of CT is an independent prognostic factor of survival this homogenous group of advanced NSCLC treated with cisplatin and gemcitabine. Baseline Hb should be considered as prognosis factor for survival in addition to ECOG. [Table: see text] No significant financial relationships to disclose.
Diagnostic strategy based on preoperative serum CEA levels in clinical stage IA NSCLC
Authors: Sawabata N. , Okada M. , Higashiyama M. , Nakagawa K. , Miyake M. , Maeda H. , Matsumura A. , Matsumura A. , Okumura M. , Taki T. , Kodama K. 
Published: March 2020

17011 Background: Following surgery, clinical stage IA NSCLC diagnosed using non-interventional examinations is occasionally pathological stage III or IV. The level of carcinoembryonic antigen (CEA) in serum has been reported to be a predictor of up-staging to advanced stages, however, there are few multi-center studies of serum CEA that utilized a short accrual period. Methods: A multi-center retrospective study was performed to assess serum CEA level as a predictor of advanced stage in 862 consecutive patients with clinical stage IA NSCLC from 2002 to 2004. The subjects were 493 males with a mean age of 65.2 years old, 460 of whom were smokers, who had a total of 689 adenocarcinomas with a mean tumor size of 19.5 cm. They were divided into 4 groups by smoking status and adenocarcinoma histology, after which AUC was calculated using an ROC curve, which provided an estimate of the probability efficiency of pathological diagnosis of stage III or stage IV. When AUC was greater than 0.7, sensitivity, specificity, and positive predictive values were calculated, and multivariate Cox regression analysis was performed to confirm independence. Results: There were 72 cases (8.1%) in an advanced stage. AUC was greater than 0.7 in the group of non-smokers with an adenocarcinoma (n = 413), in which the sensitivity, specificity, and positive predictive values were 0.14, 0.97, and 0.64, respectively, with a CEA cut-off level of 20 ng/ml. Thus, serum CEA level was shown to be an independent predictive factor. Conclusions: In smokers with an adenocarcinoma, a high level of CEA in serum was frequently found in those with pathologically advanced disease, thus intervention should be mandated in such cases. [Table: see text] No significant financial relationships to disclose.
Biweekly docetaxel and carboplatin as first line chemotherapy in advanced non small cell lung cancer (NSCLC)
Authors: Fírvida J. L. , Esquerdo G. , Amenedo M. , Salgado M. , Llorca C. , González A. , Pérez E. , Cervera J. M. , Ramos M. 
Published: March 2020

17016 Background: Platinum therapy has been the backbone treatment in NSCLC. The concomitant use of platinum derivatives and taxanes has shown high antitumoral activity with moderate toxicity. To improve the therapeutic index of this combination, we performed a study with biweekly carboplatin and docetaxel. Primary objective was determination of objective response rate (ORR). Secondary objectives were time to progression, tolerability and overall survival. Methods: Patients histologically confirmed of non-small cell lung cancer, aged ≥ 18, ECOG PS 0–2, measurable lesion according RECIST criteria, adequate bone marrow, renal and hepatic function were included. Prior chemotherapy was not allowed. Patients received treatment with a combination of Docetaxel 50 mg/m2 and Carboplatin AUC-4 each 15 days for a maximum of 8 cycles. Results: Fifty patients were included between March 2004 and July 2005, 84% were male, median age was 63 years old (range 48–77), 78% had ECOG PS 0–1 and 64% of patients had stage IV. Histology was squamous cell carcinoma (54%) adenocarcinoma (36%) and large cell carcinoma (10%). A total 316 cycles were administrated (median 7, Range 1–12). Over 46 evaluable patients for response, one achieved CR, 13 PR, 21 SD and 11 PD, with an overall response rate of 30.5% (95% CI: 17.2–43.8). Median follow up of patients is 8.3 months, with a median TTP of 6.3 months and median overall survival of 11.1 months. Grade 3–4 toxicity per patient was: neutropenia (22.0%), asthenia (16.0%), anaemia (10.0%), thrombocytopenia (2%), mucositis (2%) and nauseas (2%). Conclusions: These results suggest that biweekly schedule of carboplatin / docetaxel is a safe and active regimen in first line advanced NSCLC patients. No significant financial relationships to disclose.
Gemcitabine/docetaxel (GD) vs gemcitabine/cisplatin (GC) in stage IIIB/IV advanced non-small cell lung cancer (NSCLC)
Authors: Casal Rubio J. , Vázquez Estevez S. , Vázquez Rivera F. , Amenedo Gancedo M. , Fírvida Pérez J. , Mel Lorenzo J. , Grande Ventura C. , Lázaro Quintela M. , Álvarez Gómez E. , López López R. 
Published: March 2020

17017 Background: This trial was designed to compare, in terms of response rates, the standard regimen gemcitabine/cisplatin versus a non-platin regimen, gemcitabine-docetaxel in NSCLC. Methods: The chemotherapy regimens administered were: Arm A: gemcitabine 1250 mg/m2 d1 & 8 plus cisplatin 75 mg/m2 d1; Arm B: gemcitabine 1000 mg/m2 d1 & 8 plus docetaxel 85 mg/m2 d1 repeated every three weeks. Eligibility criteria were measurable stage IV or stage IIIB with pleural effusion NSCLC (brain metastases eligible if asymptomatic) and PS (ECOG Scale) = 0–2. Results: 108 patients (pts) were included between January 2001 and August 2004, 56 in arm A and 52 in arm B. For arm A median age was 59.9 (69.7–50.1); PS 0–1: 83.3%, PS 2: 16.7; Stage IIIB/IV: 18.2/81.8%, For arm B median age was 61.4 (70.4–52.4); PS 0–1: 84%, PS 2: 16%; Stage IIIB/IV: 14/86%. A median number of 5 cycles in arm A and 4 in arm B were administered. Response rates from the 105 eligible patients were: Arm A (55 pts): CR 3.8%, PR 32.1%, SD 32.1%; Arm B (50 pts): CR 2.3%, PR 44.2%, SD 20.9%. Median overall survival (OS) was the same in both arms, 8.9 months (6.3–10.5) in arm A and 8.9 months (3.9–10) in arm B (p = 0.525); median time to progression disease (TTPD) was 6 months (4.2–7.1) in arm A and 5.5 months (4.1–7.2) in arm B (p = 0.607). Toxicities include, in Arms A and B respectively: Grade 3–4 neutropenia 49.1% and 41.2%, with neutropenic fever in 1.8% and 2%; Grade 3/4 thrombocytopenia 30.9/0% and 3.9/0%; Grade 3/4 anemia 14.5/0% and 3.9/0%. Non-hematological toxicity grades 3–4 were similar in both arms, with the exception of nausea and vomiting, (16.3% and 2% in arm A and B respectively); renal and hepatic toxicity (hepatic 5.6% vs. 12.7% and renal 3.7% vs. 0%). Conclusions: The overall response rate was higher in the combination gemcitabine-docetaxel, although there are no significant differences in OS and TTPD. GD is an active non-platin regimen and a good first treatment option for advanced NSCLC. No significant financial relationships to disclose.
The predictive factors and patient-selection associated with the survival benefits of gefitinib in patients with advanced non-small cell lung cancer (NSCLC)
Authors: Funada Y. , Satouchi M. , Miyagawa T. , Urata Y. , Shimada T. , Yoshimura S. , Watanabe Y. , Kurata T. , Adachi S. , Takada Y. , Negoro S. 
Published: March 2020

17020 Background: Gefitinib, an inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, has shown meaningful antitumor activity for advanced NSCLC. Survival benefit of treatment with gefitinib has not been shown in unselected patients, however heterogeneity in survival outcomes between sub-group (histological types, gender, smoking status and ethnicity) of patients has been observed. The aim of this study was to identify the potential predictive features associated with the survival benefit of treatment with gefitinib. Methods: All NSCLC patients who began taking gefitinib during the period from July 2002 until July 2005 in our institute were retrospectively reviewed. Potential factors analyzed included age, gender, smoking history, performance status (PS), histology, stage, and prior chemotherapy. Results: Overall 221 patients were analyzed. The overall response rate of gefitinib was 26.7%. Median survival time (MST) was 8.0 months. MST of patients whose tumor response was partial response (PR) was 34.5 months. Univariate analysis revealed that the predictive factors of favorable survival were female (p = 0.001), never-smoker (p < 0.0001), good PS (p < 0.0001) and adenocarcinoma (p < 0.0001). Multivariate analysis showed that never-smoking history (p = 0.005), adenocarcinoma (p = 0.004), and better PS (P < 0.001) were significant independent predictors of long survival. The Brinkman index (BI), number of cigarettes per day multiplied by number of years smoked, was associated with survival benefit. MST was 17.6 months in the BI = 0 group (never-smokers), 9.7 months in 1 ≤BI <500, 6.9 months in 500 ≤BI <1000, 4.4 months in 1000 ≤BI <1500, and 4.0 months in BI ≥1500. Conclusion: Never-smokers and adenocarcinoma are predictive factors for prolonged survival. As for smoking status, lower BI is associated with better prognosis after treatment with gefitinib. Therefore, histological factors and smoking status must be considered when treating with gefitinib. No significant financial relationships to disclose.
Serum levels of administered gefitinib correlate with the time to treatment failure in non small cell lung cancer patients
Authors: Nishio M. , Ohyanagi F. , Horikike A. , Ishikawa Y. , Satoh Y. , Okumura S. , Nakagawa K. , Nishio K. , Horai T. 
Published: March 2020

17027 Background: Gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, has been shown to have clinical activity against non-small cell lung cancer (NSCLC). The aim of the present study was to clarify the relationship between serum gefitinib levels and clinical efficacy in patients with advanced NSCLCs. Methods and Results: Sera from 89 cases (51 men and 38 women) were obtained after 2 weeks gefitinib (250 mg/day) monotherapy. The average gefitinib level was 429.4 ± 214.8 ng/ml (mean ± SD) with 17-fold variability observed. No significant variation was observed with reference to gender, smoking history or performance status. There was no direct link between gefitinib level and tumor response, but a significant positive correlation was evident with time to treatment failure in 44 patients receiving gefitinib for more than 3 months (R = 0.365, P = 0.0144). Conclusions: These results suggested that a dose response may exist for time treatment failure in the patients who benefit from gefitinib. Dose modification in accordance with the serum gefitinib level may thus improve the efficacy of gefitinib for NSCLCs. [Table: see text]
Neoadjuvant weekly paclitaxel/cisplatin chemotherapy (WTP) with concurrent thoracic chemoradiation followed by surgical resection for stage IIIA (pN2) non-small cell lung cancer (NCLC): Phase II study
Authors: Kim S. , Sohn H. , Suh C. , Ryu J. , Choi E. , Kim Y. , Kim D. , Park S. , Kim W. , Lee J. 
Published: March 2020

17036 Background: To investigate the role of weekly chemotherapy with paclitaxel/cisplatin and concurrent thoracic radiation (RT) as neoadjuvant therapy before surgical resection for patients with N2-IIIA NSCLC. Methods: Patients with pathologically proven N2 (pN2) and operable stage IIIA NSCLC were eligible. Six weekly chemotherapy with paclitaxel (50 mg/m2)/cisplatin (20 mg/m2) was given with concurrent thoracic RT (1.8 Gy/fraction once a day, 45 Gy) during 5 weeks. Chest CT, whole body PET were checked before and 3 weeks after chemoradiation. For the patients without clearing pN2 nodes or with pT3 after surgical resection, boost RT (20 Gy) was given. Results: From Jan. 2002 to Nov. 2005, 38 patients were enrolled. Median follow-up time was 20 months: gender (male: female, 30:8,), age (median 56, 42–67). Of them, 31 patients underwent surgical resection. Three patients showed brain metastasis during chmoradiation. Two patients refused surgical resection after chemoradiation. One patient showed severe radiation pneumonitis and was not fit for the operation. One patient showed lung to lung metastases before surgical resection. Of the 31 patients who underwent surgical resection, 14 (45.2%) showed pN0–1, and 7 (22.6%) showed pathologic complete remission (CR). Three year overall survival rate of all patients was 37.7% (median 35.9 months) and 3 year progression free survival was 34.2% (median 18 months). In univariate analysis, clearing N2 node and pathologic CR after surgery were the factors that could predict long-term survival. And the 2nd PET after chemoradiaiton could not expect clearing N2 nodes after surgical resection: sensitivity 44%, specificity 46%. As toxicities of WTP, hypersensivity reaction to paclitaxel and pneumonia with neutropenia were noted in 1 patient each. Severe radiation pneumonits was noted in 4 (of them 3 were given 65 Gy). Conclusions: WTP followed by surgical resection for N2-stage IIIA NSCLC was feasible. Clearing N2 nodes or pathologic CR after surgical resection were the factors of long-term survival. The usefulness of 2nd PET to expect the clearing N2 nodes was not adequate. No significant financial relationships to disclose.
mRNA expression of signal transducer and activator of transcription (STAT5), disheveled-3 (Dvl-3) and dicer in early-stage non-small-cell lung cancer (NSCLC)
Authors: Cecere F. , Rosell R. , Taron M. , Ceribelli A. , Milella M. , Mendez P. , Cuello M. , Visca P. , Facciolo F. , Cognetti F. 
Published: March 2020

17038 Background: STAT5 plays a role in angiogenesis and metastasis. Activation of STAT5 occurs through dysregulation of growth factor receptor tyrosine kinases (TK) (including EGFR TK mutations), non-receptor TKs or Janus kinases. Dvl-3, a critical mediator of the Wingless-type (Wnt) signaling pathway, contributes to self-renewal of stem cells. Dicer has a key role in processing microRNAs required for stem cell regulation. We assessed mRNA expression of STAT5, Dvl-3 and Dicer in early-stage NSCLC. Methods: cDNA was derived from paraffin-embedded primary tumors of 47 surgically resected, early-stage NSCLC patients. Real-time quantitative reverse transcriptase PCR was used to measure STAT5, Dvl-3 and Dicer mRNA levels relative to the internal reference gene β-actin. Results: Median expression levels were: STAT5, 0.66 (0.15–6.03); Dvl-3, 3.69 (1.02–25.83); Dicer, 4.53 (1.22–21.96). STAT5 levels for squamous cell carcinoma (SCC) were 0.57 vs 0.89 for non-SCC (P=0.01), while Dicer levels were higher in SCC (4.25) than in non-SCC (2.60) (P = 0.01). A strong correlation between the levels of Dvl-3 and Dicer was found (rho = 0.49; P < 0.001). 90% of females had low Dicer mRNA levels (P = 0.01). No other correlation between mRNA levels and patient characteristics was found. Conclusions: High levels of Dvl-3 are associated with SCC. The close correlation between Dvl-3 and Dicer levels may indicate that Dicer could process a class of microRNA that activates the Wnt pathway. In non-SCC, overexpression of STAT5 could be involved in tumor angiogenesis. These 3 transcripts could be potential predictors of metastasis and ideal targets for individualized treatment. No significant financial relationships to disclose.
Efficacy and safety profile of oxaliplatin and docetaxel in patients with advanced non-small cell lung cancer (NSCLC)
Authors: Santos E. S. , Raez L. E. , Rosado M. , Lopes G. , Roman E. , Kumar P. , Tolba K. , Silva O. , Rocha-Lima C. , Hamilton K. 
Published: March 2020

17061 Background: Platinum-based doublets are used as treatment for advanced or metastatic non-small cell lung cancer (NSCLC), but chemotherapy must be tailored to decrease side effects. Oxaliplatin is more potent than cisplatin, requiring fewer DNA adducts to provide equivalent cytotoxicity in vitro studies. Oxaliplatin was active as a single agent and in combination with vinorelbine, paclitaxel, and gemcitabinein phase II studies of patients with NSCLC. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage-IIIB or -IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to 6 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints were progression-free and overall survival (PFS and OS), and safety. Results: Twenty-nine patients were treated; 15 (51.7%) were women, 25 (76%) were white, 17 (58.6%) were hispanic, 21 (72.4%) had adenocarcinomas, 24 (83%) had a PS ECOG 1, 93% had stage-IV disease and 28% had brain metastases. There were 10 partial responses in 27 evaluable patients for an ORR of 37% (90% confidence interval [CI], 21.7%–54.7%). Median PFS for 29 treated patients was 4.6 months (95% CI, 2.6–6.5 months); 12-month PFS was 14.8% (95% CI, 3.4%– 34.0%). Median OS was 10.9 months (95% CI, 8.9–16.8 months); 12-month OS was 40% (95% CI, 18.5%–60.8%) and 18-month OS was 16% (95% CI, 1.4%–45.7%). There were no unusual or unexpected adverse events. The most common grade-3 and -4 toxicities were anemia (14% of patients) and hyperglycemia (10%). There were only 2 reports of neutropenia; both were grade 1 or 2. Conclusions: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and offers a feasible treatment alternative for patients with advanced or metastatic NSCLC. [Table: see text]
Phase I/II trial of doranidazole (PR-350) and concurrent thoracic radiotherapy (TRT) in patients (pts) with locally advanced (LA) non-small cell lung cancer (NSCLC)
Authors: Takeda K. , Negoro S. , Nakagawa K. , Segawa Y. , Nishimura Y. , Fukuoka M. , Ariyoshi Y. 
Published: March 2020

17064 Background: PR-350 was a nitoroimidazole derivative as a hypoxic cell radiosensitizer with low toxixity, developed by POLA Chemical Industries Inc.(Yokohama, Japan). We undertook this phase I/II trial to characterize the safety, pharmacokinetics (PK), and antitumor activity of the combination chemotherapy of platinum agent and paclitaxel followed by PR-350 and concurrent TRT in pts with LANSCLC. This trial was conducted by West Japan Thoracic Oncology Group (WJTOG). Methods: Major eligibility included 20–74 years old, histologically or cytologically proven NSCLC, surgically unresectable stage IIIA and IIIB, no prior therapy, ECOG performance status of 0 to 1, and adequate organ functions. All pts received two cycles of cisplatin of 80 mg/m2 and paclitaxel of 180 mg/m2 before radiotherapy with PR-350. The radiation dose was 60 Gy in 30 fractions of 2 Gy over 6 weeks. PR-350 dose of 2000 mg/m2 was administered as a 25 minutes intravenously prior to irradiation daily. The starting consecutive days were 10 times with daily TRT, and the times were escalated in increments of 10 times for successive groups of 6 new pts. PK studies of PR-350 were performed on the first day and the end. Induction chemotherapy of carboplatin (AUC = 6) and paclitaxel (200mg/m2) was also permitted in phase II portion. Results: 37 pts were enrolled into this trial. Major severe toxicity was radiation pneumonitis, which developed 2 treatment related deaths (TRD). Grade 3 or more esophagitis was not developed in this trial. PR-350 was able to administered 30 consecutive days with concurrent TRT. Overall response rate was 67.6% (95% CI: 50.2–82.0%). Median survival time was 16.8 months (95% CI: 12.1–21.9 months), and 1 and 2 year survival rate were 64% and 21%, respectively. No cumulative effect was demonstrated among 3 dose levels by PK studies. Conclusions: Induction chemotherapy followed by TRT with 30 times of PR-350 was well tolerated and promising for the treatment of LANSCLC. [Table: see text] No significant financial relationships to disclose.
Role of (18) F-FDG PET scanning in detecting osseous metastases in non-small cell lung cancer (NSCLC) in a community setting: A retrospective data analysis
Authors: Pulagam S. R. , Johnson J. , Nelson K. , Kim B. , Kirchner L. , Mamounas E. 
Published: March 2020

17067 Background: Metastasis from a distant site is the most common neoplastic process involving bone. Accurate staging of NSCLC is critical for effective management. Bone scans have been traditionally used for diagnosing bone metastases in NSCLC. Recently, PET scanning has been shown to be effective in detecting bone metastases in several studies. In NSCLC, using a single PET scan to evaluate both the primary tumor and bone metastases might be more cost-effective and if the accuracy of PET scanning for detection of bone metastases can be established, the need for bone scanning may be obviated. We performed a retrospective comparison between PET scan and bone scan in NSCLC patients diagnosed and treated in a community hospital setting. Methods: 50 patients who were diagnosed with NSCLC between January 1, 2002 and December 31, 2004 and who had both PET scan and Bone scan done within 3 months of each other were included in the study. 47 patients had both investigations within 40 days duration. Data regarding all the lesions found on bone and PET scan were collected. Results: The median age of the patients was 70.5 years. Total of 20 patients were diagnosed with bone metastases by one or the other test. Of these 15 were identified with bone scan with a sensitivity of 75% (95% Confidence interval CI 56.2%–97.1%). 17 patients were identified by PET scan with a sensitivity of 85% (95% CI 45.5%–92%), p-value -0.48 compared to bone scan. 3 patients who had positive bone scan had a negative PET scan. 5 patients who had positive PET scan had a negative bone scan. Conclusions: PET scan appears to be as good as bone scan in detecting bone metastases. Unless very high clinical suspicion exists regarding bone metastases, negative PET-Scan for bone metastases should obviate the need for bone scan. [Table: see text] No significant financial relationships to disclose.