bluuebunny/crossref_metadata_2025_split huggingface dataset:
Radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with concurrent radiotherapy and gemcitabine after induction with gemcitabine and carboplatin
Authors: Michel R. M. , Gallardo-Rincon D. , Villarreal-Garza C. , Astorga-Ramos A. , Zamora J. , Martinez-Barrera L. , de la Garza J. , Arrieta O. 
Published: August 2020

e18504 Background: The combination of chemotherapy (CT) and thoracic radiation (RT) is the standard treatment for locally advanced non-small cell lung cancer (NSCLC). The most favorable CT regime, timing of full-dose CT and the best way to combine CT with RT to maximize systemic and radiosensitizing effects remain to be determined. The aim of this study was to assess the efficacy, safety and tolerability of gemcitabine concurrent with RT after induction CT (gemcitabine + carboplatin) in locally advanced NSCLC. Methods: Patients with histologically proven NSCLC IIIA and IIIB received carboplatin (AUC of 2.5) and gemcitabine (800 mg/m2) on day 1 and 8, every 21 days (two cycles), followed by conventional fractioned RT (60Gy) with concomitant weekly gemcitabine 200 mg/m2 and by consolidation CT. Survival was analyzed with Kaplan-Meier. Results: Median follow-up was of 11.9 months, 11 patients (57.9%) had stage IIIB disease. Patient inclusion was discontinued due to high grade 3/4 radiation pneumonitis events (5/19 patients, 26.3%). One treatment-related death from radiation pneumonitis occurred. The most common hematological side effects grade 3/4 were anemia and neutropenia 3/19 (15.8%) each and thrombocytopenia 4/19 (21.1%) during induction CT. Partial response was observed in 11 patients (57.9%) following induction. After concurrent chemo-radiotherapy, overall response was 68.4%. Four patients underwent surgical resection. Median progression-free survival was 12 ± 1 months (95% CI, 9.8 -14.1). Overall survival was of 21 ± 3.5 months (95% CI, 14–27.9). Conclusions: Concurrent RT with gemcitabine after induction CT with gemcitabine and carboplatin showed a high response rate. However, it is associated with excessive pulmonary toxicity. Adjustments in gemcitabine dosage during RT or changes in RT planning could reduce toxicity. No significant financial relationships to disclose.
Response and survival in African American (AA) patients (pts) with non-small cell lung cancer (NSCLC) treated with erlotinib (E)
Authors: Villaflor V. M. , Kanteti R. , Watson S. M. , Karrison T. , Vokes E. E. , Salgia R. 
Published: August 2020

e19006 Background: Pts who respond to the EGFR- tyrosine kinase inhibitors (TKI's) frequently have activating mutations in the kinase domain of EGFR or EGFR overexpression. EGFR activating mutations correlate with adenocarcinoma histology, non-smoking history, female gender, and Asian ethnicity. The presence of EGFR kinase domain mutations is predictive of response but, the relationship is not always concordant. Furthermore, mutations may not predict survival benefit with TKI therapy and other factors are likely involved. It has also been determined that EGFR and met can crosstalk, and serve as potential mechanism of resistance in NSCLC. Most data collected to date on response and overall survival with EGFR-TKI's have been in the Caucasian or Asian community. Hence we collected data specific to the AA pt as they tend to have worse outcomes stage for stage. The purpose of this study is to report the response rate, overall survival, progression free survival (PFS) and clinical characteristics of AA pts with NSCLC treated with an EGFR-TKI. We will correlate these data with EGFR mutation and c-Met expression/mutations/amplifications for markers of NSCLC. Methods: We have listed patients with NSCLC receiving E therapy over the past 5 years. We then retrospectively collected demographic data (age, race, sex, and tobacco history), tumor histology, response rates, survival data and duration of response from AA pts treated with E as single agent. The response to E was correlated with outcome. Results: Data from 44 AA pts (27 women, 17 men) on erlotinib were reviewed. Mean age was 67.1 years (range 48–89 yrs), tobacco use (37 positive, 3 negative, and 4 not recorded). Histology included NSCLC not specified-14, squamous cell- 16, adenocarcinoma-11, large cell-1 and 2 not available. Overall response rate of 13.6% (6-PR, 16-SD, 18-progessive disease, and 4 patients lost to follow up). The PFS was 4.0 months; 95% CI: (2.5–6.6 mos) and overall survival 8.6 mos; 95% CI: (7.2–30.9 mos). EGFR mutations and c-Met analysis will be provided by ASCO meeting in May 2009. Conclusions: AA survival and response rates appear similar to previous data seen with all NSCLC patients receiving treatment with EGFR-TKI's. More data and relationship to biomarkers is needed in this population. [Table: see text]
Adverse effects and associated costs with second- and third-line therapies for non-small cell lung cancer
Authors: Ye X. , Darkow T. , Reyes C. 
Published: August 2020

e19009 Background: Chemotherapies used in the treatment of non-small cell lung cancer (NSCLC) are associated with a number of adverse effects (AEs), which may increase health care use and costs as patients receive treatment for these AEs.The objectives of this study were to compare occurrence of selected AEs and associated costs among patients receiving docetaxel (D), erlotinib (E), or pemetrexed (P) monotherapy as 2nd- or 3rd-line treatment of NSCLC in a retrospective claims database. Methods: Commercial enrollees with evidence of lung cancer were identified using ICD-9-CM diagnosis codes between 6/2004 and 12/2006. Pharmacy and medical claims were used to identify patients who received D, E, or P monotherapy as 2nd- or 3rd-line treatment. AEs were identified based upon diagnosis, procedure and prescription codes. Costs were compared between cohorts on a per month basis due to variable follow-up time. Results: Of 679 patients receiving 2nd-line treatment, 110 received D, 145 received E, and 116 received P. The most frequent AE was nausea/vomiting (N/V), which occurred in 90% of study subjects. Anemia (64%), neutropenia (35%), dyspnea (34%), and other respiratory AEs (35%) were also common. Compared with D, E was associated with significantly lower rates of neutropenia (3% vs. 46%; p < 0.0001), N/V (60% vs. 100%; p < 0.0001), and dehydration (10% vs. 20%; p = 0.03). P was also associated with higher rates of neutropenia and N/V than E (22% and 97%, respectively; p < 0.0001), as well as having a higher occurrence of anemia (74% vs. 49%; p < 0.0001). Costs to manage these AEs were also lower for E, with total costs related to AEs of $1494 for E, compared with $4386 for D (p = 0.004) and $6317 for P (p < 0.0001). Of 335 patients receiving 3rd-line treatment, 33 received D, 79 received E, and 80 received P. At least one AE was experienced by all patients in the D and P cohorts, while 73 (92%) E patients experienced at least one AE (p = 0.10 vs. D; p = 0.01 vs. P). Costs to manage AEs in the 3rd-line setting were lower for E ($2765) than for P ($4718; p = 0.02), while costs for E and D ($3680) were not significantly different (p = 0.28). Conclusions: Overall, occurrence of AEs commonly associated with 2nd- and 3rd-line agents for NSCLC was less frequent and less costly among E users. [Table: see text]
Association of plasma EGFR mutations with response to first-line chemotherapy and prognosis in Chinese patients with advanced non-small cell lung cancer
Authors: Wu M. N. , Zhao J. , Bai H. , Zhuo M. L. , Wang S. H. , Yang L. , An T. T. , Wang X. , Duan J. C. , Wang Y. Y. , Wang J. 
Published: August 2020

e19017 Background: To investigate associations of plasma EGFR mutations of advanced non-small cell lung cancer (NSCLC) patients with response to the first-line chemotherapy and prognosis. Methods: Plasma EGFR mutations from 145 chemotherapy-naive patients with advanced or metastatic NSCLC were examined by using denaturing high- performance liquid chromatography (DHPLC), and associations of EGFR mutations with tumor response to chemotherapy and clinical outcomes were evaluated. Results: 37.2% (54/145) of the patients was detected to have EGFR mutations in their plasma DNA. The response rate of mutated EGFR carriers to the chemotherapy was 37% (20/54), similar to that of 31.9% (29/91) of wild-type EGFR carriers to the chemotherapy (P= 0.323). Stage IV NSCLC patients with mutated EGFR had a longer PFS than those with wild-type EGFR (4 vs 3 months, P=0.043) after the first-line chemotherapy. The median survival time and 1-, 2- year survival rate for the patients with EGFR mutations (24 months and 85.7%,43.7%) were increased than those with wild-type EGFR (18 months and 65.7%,25.9%) (p=0.0468). Cox multivariate regression analysis showed that clinical stage (IV vs IIIb), response to the first-line chemotherapy (PR vs PD), and EGFR mutations were independent prognostic factors (P=0.008, 0.000 and 0.000 respectively). Conclusions: We conclude that plasma EGFR mutations in the Chinese patients with advanced NSCLC were not associated with response to the first-line chemotherapy, but Stage IV NSCLC patients with mutated EGFR had a longer PFS after the chemotherapy. No significant financial relationships to disclose.
Results of 27 years of phase III trials for patients with extensive-disease small-cell lung cancer
Authors: Oze I. , Kiura K. , Hotta K. , Ochi N. , Fujiwara Y. , Takigawa N. , Tabata M. , Shinkai T. , Tanimoto M. 
Published: August 2020

e19021 Background: Few studies have formally assessed whether treatment outcomes for patients with extensive-disease small-cell lung cancer (ED-SCLC) enrolled in Phase III trials have improved substantially over the years. This investigation determined the trends in the outcomes for the patients in those trials. Methods: We analyzed trials that were reported between January 1991 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated using linear regression analysis. Results: We identified 55 trials initiated between 1980 and 2006, involving 10,407 patients with 116 chemotherapy arms. The number of randomized patients and the proportions of patients with good performance status (PS) increased with the passage of time. In the 1990s, increasing numbers of studies examined cisplatin-based regimens, especially cisplatin and etoposide (PE) regimens, while decreasing numbers examined cyclophosphamide, doxorubicin, and vincristine-based regimens. A scattergram of the parameters ‘year of trial initiation’ and ‘median survival time’ (MST) indicated that MST increased 0.024 months (0.71 days) per year (P = 0.198). The multiple regression analysis showed no significant survival improvement over the years (regression coefficient for the year of trial initiation = 0.004, P = 0.980). In addition, the use of PE regimens did not prolong survival, whilst the proportion of good PS patients and the assignment of prophylactic cranial irradiation were significantly associated with favorable outcomes. Conclusions: The survival of patients with ED-SCLC enrolled in phase III trials has not improved significantly over the years, suggesting the need for a breakthrough, such as the discovery of novel molecular targets. No significant financial relationships to disclose.
Phase II study of bevacizumab in combination with cisplatin and docetaxel as first-line treatment of patients (p) with metastatic non-squamous non-small cell lung cancer (NSCLC)
Authors: Ferrer N. , Cobo M. , Paredes A. , Méndez M. , Muñoz-Langa J. , Rueda A. , Álvarez de Mon M. , Sánchez-Hernández A. , Gallego R. , Torrego J. 
Published: August 2020

e19023 Background: Bevacizumab (B), in addition to platinum-based chemotherapy, is indicated for 1st-line treatment of p with advanced NSCLC other than predominantly squamous cell histology. B has been shown to improve progression free survival (PFS) and overall survival (OS) when combined with cisplatin/gemcitabine and carboplatin/paclitaxel, respectively. However, there are limited data on the safety and efficacy of B in combination with other widely used chemotherapy doublets for NSCLC. This is a single-arm, open- labeled, single-stage phase II trial of cisplatin (C), docetaxel (D) and B for NSCLC. Methods: Eligibility criteria: chemo- naïve, stage IIIB wet or IV, non-squamous NSCLC, PS 0–1, no brain metastases and no history of gross hemoptysis. P received D (75 mg/m2), C (75 mg/m2), and B (15 mg/kg iv) on day 1 every 3 weeks for up to 6 cycles, followed by B 15 mg/kg alone every 3 weeks until disease progression or toxicity. Primary endpoint: PFS. Results: 50 p were enrolled (enrollment completed): 24% female, median age 60 (36–74), PS 1: 64%, adenocarcinoma: 72%; stage IV: 92%. Two p did not start treatment. Median follow-up is 5.3 months (range 0–13.6). Median number of cycles of B was 7 (range 0–18). 56% completed 6 cycles of treatment; 24% received ≥ 12 cycles of B. Most frequent grade ≥ 3 toxicities: diarrhea (14.6%), fatigue (14.6%), dyspnea (9.8%), anorexia (4.9%), alopecia (4.9%), esophagitis (4.9%), constipation (4.9%), mucositis (12.2%), proteinuria (4.9%); hematological toxicities: neutropenia (22%), febrile neutropenia (9.8%), leucopenia (14.6%), lymphopenia (4.9%). Of interest, 41.5% developed grade <3 epistaxis and 17% hypertension (1 p grade 3). One p died due to hemoptysis. 46 p were evaluable for response: 29 PRs (ORR: 63%). 18 of 48 p have experienced progression or death with a median SLP of 7.8 months (95% CI: 6.6-NR). Median OS is 13.5 months (95% CI: 12.7–13.6; 81.2% p censored); 1-year survival is 83.9% (95% CI: 67.4%-92.5%). Conclusions: Treatment with C, D and B, followed by maintenance B in 1st line of advanced non-squamous NSCLC shows an acceptable toxicity profile and promising efficacy. Final results will be presented. [Table: see text]
A phase II trial of combination chemotherapy with irinotecan and amrubicin in pretreated patients with non-small cell lung cancer (NSCLC): Results of Okayama Lung Cancer Study Group Trial 0402
Authors: Kuyama S. , Segawa Y. , Nogami N. , Kiura K. , Takigawa N. , Shibayama T. , Hosokawa S. , Aoe K. , Tabata M. , Tanimoto M. ,   Okayama Lung Cancer Study Group
Published: August 2020

e19029 Background: We previously conducted a phase I trial of combination chemotherapy with irinotecan and amrubicin for NSCLC and found acceptable toxicity profiles with a favorable efficacy in patients with pretreated NSCLC. The aim of this phase II trial was to further evaluate its efficacy and toxicity in this population with a long-term follow-up. Methods: Primary endpoint was objective response. Patients with NSCLC previously treated with one or two chemotherapy regimens were enrolled in this trial. Irinotecan and amrubicin were both administered on days 1 and 8, every 3 weeks at doses of 100 and 40 mg/m2, respectively. Response and toxicity were assessed according to the RECIST guideline and NCI-CTC for AE v3.0. Results: Thirty-one pretreated NSCLC patients were enrolled between 2004 and 2006. A median number of courses administered was 3 (range: 1 to 6). All patients and courses were assessable for efficacy and safety. Demographics of the patients were as follows: M/F:21/10, Ad/others:21/10, ECOG-PS 0/1:12/19, and smoker/non-smoker:21/10. Platinum-based regimens were commonly used as the prior chemotherapy. Objective response was obtained in 9 of the 31 patients with a response rate of 29.0% (95%CI: 12.1–46.0%). Grade 4 leukopenia and neutropenia were observed in 6 (19%) and 14 (45%) patients, respectively, whereas thrombocytopenia were generally mild. Grade 3 febrile neutropenia was observed in 7 patients (23%), of whom two patients further developed Grade 4 and 5 septic shock each. Other grade 3 or greater non-hematological toxicities included diarrhea, vomiting, pneumonitis, liver dysfunction in 4, 1, 1 and 2 patients, respectively. With a median follow-up time of 24.2 months, median survival time and median progression-free survival time were 14.2 and 4.0 months, respectively. Conclusions: This combination seemed highly effective for pretreated NSCLC with an acceptable toxicity. No significant financial relationships to disclose.
Paclitaxel versus oral vinorelbine in patients with advanced non-small cell lung cancer (NSCLC) with performance status (PS) 2: A randomized phase II study
Authors: Syrigos K. N. , Bacoyiannis C. , Makatsoris T. , Bamias A. , Klouvas G. , Nicolaides C. , Boukovinas I. , Linardou E. , Fountzilas G. , Kosmidis P. 
Published: August 2020

e19035 Background: The optimal treatment of patients with advanced NSCLC and PS 2 is not well established. Our group has shown that single agent is equally effective to doublets. Purpose of this study was to compare efficacy and toxicity of two single agents Paclitaxel and oral Vinorelbine. Methods: 75 stage IIIb wet and IV chemotherapy-naïve for metastatic disease patients with PS 2 were randomized to either Paclitaxel 90mg/m2 weekly (group A: 36pts) or Vinorelbine 60mg/m2 weekly (group B: 34pts). Both agents were given for three weeks on and one week off. Results: A total of 70 out of 75 patients were eligible for analysis. All patient and disease characteristics were well balanced. Partial response rate (PR) was 14% (95% CI, 4.7%-29.5%) and 6% (95% CI, 0.7%- 19.7%) for groups A and B respectively. Stable disease (SD) was 17% (95% CI, 6.4%-32.8%) and 12% (95% CI, 3.3%-27.5%) respectively. These rates did not differ significantly. Median survival (OS) was 5.3m (95% CI, 3.1–7.5 m) and 3.5m (95% CI, 1.6 - 5.4 m) respectively (P=0.6). Progression free survival (PFS) was 3.2m (95% CI, 1.9 - 4.6 m) and 2.1m (95% CI, 1.8 - 2.3 m) respectively (P=0.2). There was a non-statistically significant trend for more myelotoxicity in the vinorelbine group. Conclusions: A trend for higher efficacy and less toxicity of Paclitaxel in comparison to oral Vinorelbine was observed, without however reaching statistical significance. No significant financial relationships to disclose.
Distribution of metastases in NSCLC: Economic impact of imaging
Authors: Pineda C. , Cadogan K. V. , Cadogan M. A. 
Published: August 2020

e19036 Background: Purpose: to investigate the usefulness and cost-effectiveness of routine pelvic CT scans in patients with NSCLC. Given that many patients have metastases to several organs, one important question is - “what is the frequency of metastases in the chest, the abdomen, the pelvis, elsewhere?” Methods: We retrospectively reviewed the CT data of 184 patients with Stage 4 NSCLC. The results are shown in Table 1 . Results: We found that there were 690 metastases to the chest, 205 to the abdomen, 80 to the bones, 18 to the pelvis, 13 to the brain and 23 others, not specified. These represent a relative incidence of 67%, 20%, 8%, 2%, 1% and 2%, respectively. These results are a strong indicator of the main areas that require imaging in NSCLC. If we consider the actual incidence of metastases, we find the following absolute statistics: 16 patients had pelvic involvement. This compares with 42 patients with adrenal metastases, 81 with liver metastases, 80 with bone metastases, 112 with hilar adenopathy, and 159 with mediastinal adenopathy. (See Table ) Conclusions: The cost of a CT of the pelvis varies, but is estimated at approximately $2000[Fred, Herbert L., MD, MACP. Drawbacks and Limitations of Computed Tomography: Views from a Medical Educator. Texas Heart Institute Journal 31 (2004): 345.]. The incidence of NSCLC is approximately 172,000 in 2008[Ries, LAG, et al (eds). SEER Cancer Statistics Review, 1975–2005. Surveillance Epidemiology and End Results. 2007. National Cancer Institute. 03JAN2009. http://seer.cancer.gov/csr/1975_2005/ .]. Hence, the potential annual savings accrued by not performing CT of the pelvis is approximately $344 million. These costs can be justified in a Research setting, but it is more difficult to do so in the clinical arena. [Table: see text] No significant financial relationships to disclose.
A phase II trial of adding cetuximab to cisplatin and gemcitabine as first-line therapy in advanced non-small cell lung cancer (NSCLC)
Authors: Barata F. , Parente B. , Teixeira E. , Costa A. , Fernandes A. , Pimentel F. L. , Carvalho L. 
Published: August 2020

e19043 Background: Phase II and III studies have demonstrated that the EGFR-antibody, cetuximab (Erbitux), improves efficacy parameters when added to a platinum-based chemotherapy in the 1st-line treatment of patients with advanced NSCLC. This study assessed the efficacy and tolerability of cetuximab in combination with cisplatin and gemcitabine in this setting. Methods: Patients in this multicenter, single-arm, phase II Portuguese study received cetuximab (400 mg/m2 initial dose then 250 mg/m2 weekly) in combination with cisplatin (40 mg/m2) and gemcitabine (1,200 mg/m2) for 6 cycles (21 days). Main eligibility criteria included metastatic NSCLC of any histological subtype, ECOG PS 0/1, and measurable disease. Patients with brain metastases were excluded. The primary endpoint was the overall response rate (ORR) during treatment, according to RECIST criteria. Secondary endpoints included time to progression (TTP), overall survival, and adverse events. Statistical analyses were performed for the intention to treat (ITT) and per protocol populations. ORRs and the corresponding 95% confidence intervals (CIs) were estimated and Kaplan-Meier curves were computed for TTP. Results: A total of 48 patients were enrolled between December 2006 and March 2008. Seventy five percent of the patients were men and the median age was 62.5 years (range 34–75). Median TTP was 5.0 months (95% CI 3.9–6.1 months). Best ORR were 35.4% (95% CI 22.2–50.5%) and 38.1% (95% CI 23.6–54.4%) for the ITT and PP populations, respectively. No differences in response rates were observed when EGFR status (as determined by FISH and immunohistochemistry) was taken into consideration. Ninety-six grade III/V adverse events were reported; the most common were neutropenia and thrombocytopenia (36 and 18 events, respectively). Conclusions: Adding cetuximab to cisplatin and gemcitabine demonstrated high efficacy (ORR and TTP) with acceptable toxicities in a nonselected population of patients in 1st-line treatment of NSCLC. No significant financial relationships to disclose.