bluuebunny/crossref_metadata_2025_split huggingface dataset:
Lipoplatin monotherapy: A phase II trial in second line treatment of metastatic non-small cell lung cancer
Authors: Ravaioli A. , Papi M. , Pasquini E. , Marangolo M. , Rudnas B. , Fantini M. , Nicoletti S. V. , Drudi F. , Possenti C. , Tamburini E. , Gianni L. 
Published: March 2020

18160 Background: Lipoplatin is a liposome encapsulated form of cisplatin. Phase I studies on lipoplatin showed an excellent toxicity profile of the compound. Therefore we performed a phase II trial in pre-treated patients with advanced non-small cell lung cancer (NSCLC). Methods: Nineteen patients with stage IV NSCLC pre-treated with first line chemotherapy were enrolled in our study. Patient selection criteria included: histologically confirmed malignancy type or cytological confirmation of advanced NSCLC, at least one measurable bi-dimensional lesion outside an irradiation field, stage IV disease, a life expectancy of more than 3 months, previous chemotherapy regimens, PS 0–2, age between 18 and 75, good bone marrow function (peripheral absolute granulocyte count of > 2,000/mm3 and platelet count of 100,000/mm3) and liver function (bilirubine less or equal to 1,5 mg/dl). Patients with symptomatic brain metastases or other severe illnesses were excluded from the study. Written informed consent was required from each patient prior to inclusion. The protocol was approved by the Local Ethical Commitee. We administered lipoplatin at the dose of 100 mg/m2 every fourteen days as second line chemotherapy. Primary endpoint was response rate. Results: We enrolled 19 patients, median age 64, with stage IV NSCLC. This was an open label single-arm trial. Statistical analysis was performed with the SPSS statistical program (version 11.0). Survival curves were estimated by the Kaplan-Meier method. All of the patients completed at least 6 cycles and were evaluated for response and toxicity. After 19 patients were treated we obtained only one partial response (5.2%) and three stable diseases (15.9%) and the study was stopped. Median time to progression was four months and median survival time was 7 months. Conclusions: In this study lipoplatin as second line drug demonstrated a lower activity in comparison to other drugs used in second line treatment. Nevertheless at the light of the excellent safety profile shown we think that the possibility to increase the dose in a new phase I-II study with escalation of the dosage should be considered. No significant financial relationships to disclose.
Phase II trial of bevacizumab plus pemetrexed and carboplatin in previously untreated advanced nonsquamous non-small cell lung cancer
Authors: Dalsania C. J. , Hageboutros A. , Harris E. , Krieger K. , Vora C. , Stevenson J. 
Published: March 2020

18163 Background: A randomized phase III trial has demonstrated the efficacy and safety of high dose bevacizumab (15 mg/kg) with carboplatin and paclitaxel in previously untreated advanced nonsquamous NSCLC (Sandler et al, NEJM 2006). Pemetrexed has also shown significant activity in advanced NSCLC. Clinical investigation of combination bevacizumab (BEV), pemetrexed (PEM) and carboplatin (CARBO) is therefore of interest in this population. Methods: Phase II, open label study in stage IIIB/IV NSCLC: eligible patients have non- squamous histology and no prior chemotherapy, brain metastasis, gross hemoptysis, tumor proximity to major vessels, uncontrolled hypertension or anticoagulation. All patients receive PEM (500 mg/m2), CARBO (AUC 6) and BEV (15 mg/kg) every 21 days. Patients are pretreated with vitamin B12 1,000 mcg every 9 weeks and folic acid 1 mg daily. Responses are assessed every 2 cycles. Patients with CR, PR or SD receive maximum of 6 cycles followed by BEV (15 mg/kg) maintenance. Our primary objective is to determine time to progression and secondary objectives include response rate, overall survival, and safety of the combination. Results: 14 patients (9 female/ 5 male; median age 62 years; range 34–77; 2 stage IIIB/12 stage IV, all ECOG PS 0 or 1) have been entered. Median number of cycles received is 5.5 (range 2 - 15). 12 patients are evaluable for response. 9 patients continued to have disease control at a median duration of 20.2 weeks (range 5–52) with 6 PRs and 3 SDs (response rate 60%; disease control rate 75%). 5 patients proceeded to BEV maintenance with 2 still ongoing. Overall survival data is immature to date. Toxicity data is available for all patients. Grade 3/4 toxicities have included neutropenia (4), nausea/vomiting (2), BEV related allergic reaction (1) and epistaxis (1). Conclusions: Combination BEV, PEM and CARBO is safe, well tolerated and shows promising activity to date. The regimen is not associated with alopecia, neuropathy or arthralgias/myalgias, and is conveniently administered. Enrollment continues and updated results will be presented. No significant financial relationships to disclose.
Phase II study of irinotecan based fourth-line chemotherapy for gefitinib therapy-failed non-small cell lung cancer (NSCLC)
Authors: Lee S. , Lee K. , Lee E. , Lee S. , Kim J. , Shin C. , Jung K. , Shim J. , In K. , Kang K. , Yoo S. 
Published: March 2020

18164 Background: Despite the undoubted gains from EGFR TK inhibitor therapy as 2nd or 3rd line chemotherapy, most of them will relapse during treatment. Among these patients, they might be young, with good performance status, and their disease is expressed with only minor symptoms. The objectives of this study were to evaluate the antitumor efficacy and safety of irinotecan based regimen as 4th line therapy for refractory or recurrent to gefitinib treatment. We report our experience with irinotecan-based 4th line chemotherapy. Methods: Eligibility required proven NSCLC refractory or recurrent after 3rd line chemotherapy(gefitinib), measurable lesions by RECIST, and ECOG PS 0–1. Irinotecan (60mg/m2, day 1,8,15) and/or cisplatin (60 mg/m2, day 1) were administered every four week for at least 2 course. We analyzed for time to tumor progression (TTP) for first, response rates and toxicities. Results: Since June 2004, 17 patients (consisting of 9 with squamous cell, 7 with adeno-, and 1 with NSCLC not further specified) with a median age of 61 years were enrolled, with 1 drop out during treatment. Chemotherapy was administered for a median 2 courses (range 2–6). Median TTP was 91 (range 35–210) days. Two pts achieved a PR and 5 pts a SD. Disease control rate was 41.2%. Response rate was 11.8%. Toxicity of grade 3 or 4 consisted of neutropenia (35.3%), anemia (29.4%), thrombocytopenia (17.7%), nausea (17.6%), and diarrhea (23.5%). There were no treatment related deaths. Conclusions: This irinotecan based chemotherapy for EGFR TK inhinbitor therapy failed NSCLC patients showed promising efficacy with tolerable toxicity. Irinotecan based chemotherapy may be considered a potential therapeutic option for 4th line chemotherapy in well selected patients. No significant financial relationships to disclose.
Low SER versus high SER thoracic radiotherapy in the management of limited-stage small cell lung cancer
Authors: Lee K. , Lee S. , Lee S. , Kim J. , Shin C. , Shim J. , In K. , Kang K. , Yoo S. 
Published: March 2020

18170 Background: Patients with small-cell lung cancer account for about 20% of all lung cancer patients, with only one third of the patients presenting with limited disease. Although the combinations of chemo and radiation therapy have improved the prognosis substantially, the optimal chemoradiotherapy remains controversial in LD-SCLC. There are many reports that the overall duration of the chemoradiotherapy package is the most relevant predictor of the outcome. Therefore we tested SER beginning with the start of any treatment until the end of radiotherapy in patients with LD-SCLC. Methods: We enrolled the patients who were diagnosed as SCLC histologically in Korea University Medical Center from 2003 to 2006. All of them presented with limited disease. We divided them into two groups; the low SER (within 60 days of SER) and the high SER group (over 60 days). The patients were treated with thoracic radiotherapy and platinum based topoisomerase inhibitor. Overall survival was analyzed with a Cox model adjusted for performance and the chemotherapy regimen. Results: Of 29 patients, 16 patients were in low SER and 13 patients were in high SER. Low SER, as compared with high SER, significantly prolonged survival rate (p=0.028). We evaluated the radiation effect by the time between the start of chemotherapy and the start of radiotherapy, below 30 days and above 30 days, but there were no statistically comparable difference in there survival time between the two groups (p=0.176). The survival times of the patients were increased by 3.094 times in the low SER (95% C.I, 1.083 to 8.840, p=0.028) and by 6.901 times in ECOG groups 0 or 1 compared with group 2 (95% C.I, 1.563 to 30.468, p=0.018). There were no statistically significant increases in the side effects: pneumonitis, esophagitis, and BM suppressions. Conclusions: The cumulative survival of the patients in the low SER group is higher than for patients in the high SER group. The SER may facilitate a more rational design of combined-modality treatment in rapidly proliferating tumors. [Table: see text] No significant financial relationships to disclose.
Phase II study of weekly docetaxel plus cisplatin as first-line therapy in advanced or metastatic non-small cell lung cancer (CHN TAX-206)
Authors: Chu D. , Li J. , Zhang X. , Liu J. , Chen Z. , Lin Y. , Wang Y. 
Published: March 2020

18173 Background: There has been increasing interest in the use of weekly administration of docetaxel as a way of reducing its hemotologic toxicity. Weekly docetaxel plus cisplatin has also shown promising efficacy and well tolerability for first-line treatment of advanced or metastatic NSCLC in our previous phase I study (2002 ASCO, abstract No 2744). We conducted this phase II trial to further evaluate this regimen’s efficacy and toxicity. Methods: Patients with histologically confirmed stage IIIB or IV NSCLC were treated with docetaxel (35 mg/m2, 30 min. iv. infusion) on days 1, 8, 15 and cisplatin (75 mg/m2, 30 min. iv. infusion) on day 1 repeated every 4 weeks for up to 6 cycles. Pts received oral dexamethasone 7.5 mg twice daily from the day before chemotherapy and consecutive two days thereafter. The primary endpoint of this phase II study is efficacy of the regimen. Results: A total of 83 patients were enrolled from July 2002 to June 2004, 75 patients were evaluable for response and 83 for safety. Median age was 55 years (range 29–70 years); and 69.9% were male; adenocarcinoma/squamous cell carcinoma/others (65/12/6); stage IIIB /IV( 47/36); ECOG PS 0/1(52/31). Median number of chemotherapy cycles was 3(1–5). One CR (complete response) and 22 PR (partial response) were achieved with an ORR of 30.7% in the evaluable patients. The 1-year survival was 48.6% with a median survival of 10.7 months (range: 3–34 months). Neutropenia was the most common adverse event, though most were mild; Grade III/IV toxicities per patient were: Neutropenia (15.6%), asthenia (11%), skin/nail toxicity (10.8%) and vomiting (9.6%). Febrile neutropenia was not observed. Conclusions: In the present study, the combination of weekly administration docetaxel combining with cisplatin appears well tolerated with very low frequency of severe hematologic toxicity and similarly efficacious as 3-weekly docetaxel in NSCLC pts. No significant financial relationships to disclose.
Retrospective analysis of pulmonary neuroendocrine/carcinoid tumors at Ohio State University
Authors: Ort E. M. , Confer P. , Otterson G. A. 
Published: March 2020

18176 Background: Neuroendocrine tumors are a unique malignant neoplasm which can arise from the respiratory tree. Bronchial neuroendocrine tumors account for 25% of all neuroendocrine tumors, but only about 1–2% of all lung cancers. The epidemiology, clinical behavior, treatment, and prognosis of carcinoid tumors differ from other lung malignancies in significant ways. Located most often in the major bronchi, these tumors secrete neuroendocrine granules such as serotonin, histamine, and prostaglandins. Classic carcinoid syndrome (diarrhea, flushing, palpitations, wheezing), however, is rare in these patients. Treatment is primarily surgical resection for cure. The purpose of our study was to identify the experience with these malignancies at our institution and compare it to other series. Methods: A total of 64 patients were identified using diagnostic codes via our institutional cancer registry from 1980–2006. Poorly-differentiated neuroendocrine tumors and small cell lung cancer cases were excluded from analysis. Data collected included survival after diagnosis, staging, epidemiologic characteristics, and treatment. Additional variables included smoking history, laterality, and tumor staging. Results: The patient age distribution ranged from 17 years old to 82 years old, with a median age of 57 years old. Most of the patients were female (73%). Tobacco use is variable in carcinoid - 54% of our patients were never smokers, whereas 17% were previous smokers, 20% were current smokers, and history was unknown in 7%. Staging was unknown in over half of the patients. Treatment was generally surgical; lobectomy (40%) was the most common intervention, followed by wedge resection (17%), radiation therapy (14%), bronchial sleeve resections (3.5%), and pneumonectomies (3.5%). Survival was generally good - at the time of last contact, 50 patients (78%) were still alive with a median follow up of 39 months since diagnosis. Conclusion: Neuroendocrine tumors of the bronchial tree remain a unique and uncommon malignancy among lung cancers. The findings at our medical center are consistent with reported series as far as epidemiologic characteristics, treatments, and outcomes. The future direction of non-surgical therapy in this malignancy remains investigational. No significant financial relationships to disclose.
Multi-institutional phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC)
Authors: Sasaki J. , Uramoto H. , Kashiwabara K. , Kishi H. , Moriyam E. , Ushijima S. , Fujii S. , Senba H. , Okamoto I. 
Published: March 2020

18179 Background: Because elderly pts may tolerate platinum-based combination chemotherapy poorly, single-agent chemotherapy is selected for the treatment regimen. However, retrospective subgroup analyses have consistently indicated that elderly pts indeed benefit from platinum-based combination chemotherapy as well as their younger counterparts. This phase II study evaluated the efficacy and safety of carboplatin-gemcitabine combination chemotherapy in elderly pts with advanced NSCLC. Methods: Fifty-four pts aged more than 70 years old (median, 77; range, 70–88) with previously untreated advanced NSCLC were enrolled on this trial. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Pts received carboplatin at an area under the curve of 4 mg/ml/min on the first day and gemcitabine at 1000 mg/m2 on the first and eighth day of consecutive 3 week periods. The primary endpoint was to determine the objective response rate of this platinum-doublet regimen. The RECIST criteria were used to measure response. Results: Enrolled pts included 15/39 with stage IIIB/IV diseases. Fifty-one out of enrolled pts were eligible for efficacy and safety analyses. The median number of treatment cycles was 4 (range, 1–7). Fifteen partial responses (response rate: 29%) were obtained. The median TTP was 118 days. Hematological toxicities of grade 3/4 included leukopenia (46%), neutropenia (72%) and thrombocytopenia (50%). Non-hematological toxicities of grade 3/4 included nausea (6%), appetite loss (7%), fatigue (7%) and infection (9%). Conclusions: The combination carboplatin-gemcitabine at these doses has shown activity with a favorable toxicity profile for fit elderly pts with advanced NSCLC. No significant financial relationships to disclose.
Expression of Bax and Bcl2 proteins in small cell lung cancer (SCLC)
Authors: Badzio A. , Krajewska M. , Elsaleh H. , Kowalczyk A. , Kurowski K. , Jassem J. 
Published: March 2020

18189 Background: Bax and Bcl2 proteins are members of Bcl-2 family which plays a critical role in the regulation of apoptosis. There are few data on the occurrence and clinical relevance of these proteins in SCLC. Methods: We have analyzed expression of Bax and Bcl2 in 86 SCLC patients. All patients had limited disease and were treated with surgery followed by chemotherapy between 1982 and 2001 (median follow up 2 years). In all cases the diagnosis of SCLC was established only after the examination of surgical specimen. This series included 59 males and 22 females, 11 T1, 46 T2, 13 T3 and 11 T4 tumors, 41 N0, 15 N1, 24 N2 and 1 N3. Expression of both proteins was evaluated by immunohistochemistry and scored, taking into account proportion of cells with positive staining and staining intensity. H-score was calculated as a proportion of positive cells times staining intensity. Continues data on H-score were used to assess relationships with clinical data. Results: Median H-scores for Bax and Bcl2 were 70 (range 0–300) and 90 (range 0–300) respectively. The positive immunostaining rates (cut-off point of 10%) for Bax and Bcl-2 in the entire group were 81% and 79% respectively. Bax and Bcl-2 expression did not correlate with any clinicopathological parameters such as age, tumor size, lymph node involvement and stage of the disease. Survival was not influenced by expression of Bax (p=0.6) or Bcl2 (p=0.86). There was a significant positive correlation between Bax and Bcl2 expression rates (p=0.018, regression coefficient 0.23). Conclusions: Bax an Bcl2 proteins are commonly overexpressed in SCLC, with tendency for co-expression. Clinical relevance of these markers is questionable in this patient cohort. No significant financial relationships to disclose.
What is the place of clinical variables in advanced non-small cell lung cancer (NSCLC) patients treated with chemotherapy?
Authors: Berhoune M. , Fabre-Guillevin E. , Banu E. , Scotte F. , Bonan B. , Medioni J. , Cojocarasu O. , Rideller K. , Ayllon J. , Levy E. 
Published: March 2020

18197 Background: Chemotherapy (CT) has shown its effectiveness in symptom control and quality of life improvement in advanced NSCLC patients. The therapeutic strategy and some clinical variables could have a major impact on outcome. Methods: Our retrospective analysis evaluated the impact on overall survival (OS) of the clinical benefit (CB), ECOG performance status (PS) and toxicity, function of treatment. CB was defined as disease-related symptoms improvement according to hospitalization report. Only grade III-IV CTC-NCI version 2 toxicities have been considered. OS was calculated between start of CT and death or last follow-up. Multivariate Cox regression analysis including CB, PS, toxicity and age, stratified by AJCC initial stage was used. Results: Data of 68 consecutive stage IIIB-IV patients treated in a single French centre were analyzed. Chemotherapy was platinum-salt based in 88, 45 and 25% of pts for the first, second and third-line, respectively. Median age was 61 years, 37% were women. More than half (66%) were metastatic and 14% were previously irradiated. Median survival was 14 months (95% CI, 6.1–21.8), 53 % of patients are dead. The risk of death PS-related was multiplied by 2.3, 2.4 and 5.3 for the first, second and third-line of CT, respectively. PS and CB were initially associated with OS (first and second-line CT), but after the third-line of CT only PS was significantly related with OS. The risk of death reduction induced by a CB was 59, 82 and 29%, respectively. Less toxicities during CT were associated with a better OS (an unsignificant 20- 30% risk of death reduction), independently of the chronology of CT. Older pts >70 years have a higher risk of death (HR=1.87), independently of the CB and treatment-related toxicities in the multivariate analysis (P=0.18), sex-adjusted. Conclusions: No matter how many lines of CT are used for a specified patient, the ECOG PS was a patient-related variable with a dominant impact on the outcome. CT must be less toxic in order to achieve a CB and ameliorate the PS. No significant financial relationships to disclose.
Targeting the therapy: Octreotide in thymoma relapse
Authors: Zampa G. 
Published: March 2020

18199 Background: Thymomas are rare slowly growing neoplasms, associated with myasthenia gravis, hypogammaglobulinemia and pure red-cell aplasia. About 40% of thymomas are invasive and some well encapsulated tumor recur years after surgical resection. 5 years survival rate in patients with noninvasive thymomas is 70 - 85% and decreases at 50 - 67% for invasive thymomas with the worst trend for stage IV (23%). Recurrence rate is 2% for stage I thymomas while for stage II and III is 28% and it decreases to 5% when thymectomy is followed by RT. Thymomas have a high content of somatostatin receptors and show high Indium-labeled octreotide (111In-DTPA- D - Phe - octreotide) uptake when octrescan is performed. Methods: From 1997 to 2006 we treated 45 consecutive patients, age ranged from 19 to 84, with tymoma histological diagnosis. 12 patients had miastenia gravis, 1 SLE and 1 autoimmune pericarditis. In our series 36 pt performed toracotomy, 28 underwent chemotherapy and 23 underwent radioterapy. 25 patients (89%) chemotherapy treated showed stable disease at CT examination while 3 of 28(11%) cases who underwent chemotherapy showed progression disease. The chemotherapy schedule was PAC used both in neoadjuvant than in adjuvant setting. On the basis of positive octreotide uptake, after the patients’ informed consent had been obtained, we treated, 14 of 20 pt resulted scintigraphically positive, with octreotide (20 mg) every 2 weeks. Six of them refused treatment. Treatment was well tolerated and no side effects were reported.We monitored CgA and NSE. Results: At CT and Octreoscan examination, after octreotide treatment, 5 (35.7%) patients showed stable disease and also CgA and NSE decrease. In 2 (14.2%) cases we observed progression disease and in 4 (28,5%) cases partial response (decrease of mediastinic masses evaluated at previous CT examination). Conclusions: Treating thymoma recurrences or residual disease with octreotide seems to be feasible and safe. All pts treated showed good compliance. Positive scintillography gives the oncologist the possibility to address a new target, the somatostatin’s receptor, through the octreotide. No significant financial relationships to disclose.