Single Agent Sequential Chemotherapy in Non-Hodgkin's Lymphomas

1973 ◽  
Vol 59 (3) ◽  
pp. 219-238 ◽  
Author(s):  
Silvio Monfardini ◽  
Gabriele Tancini ◽  
Marco Gasparini ◽  
Federico Pizzetti ◽  
Mario De Lena ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Median Survival ◽  
Alkylating Agents ◽  
Performance Status ◽  
Single Agent ◽  
Sequential Chemotherapy ◽  
Clinical Resistance ◽  
Extranodal Disease ◽  
Well Differentiated ◽  
Hodgkin's Lymphomas

A retrospective analysis of 118 patients with non-Hodgkin's lymphomas who received one or more drugs of single agent chemotherapy was conducted to determine the relationship between the histopathologic category of lymphoma, based on the classification proposed by Rappaport et al., and the results (type of regression and survival) of sequential chemotherapy. In 96/118 cases, slides were available for histopathologic reclassification. Patients were selected according to the following criteria: chemotherapy with single agents administered in sequence (e.g. alkylating agents, vincristine, adriamycin, bleomycin); change in drug administration only after an adequate course and either no response or clinical resistance after prior regression; measurable disease; performance status greater than 40. Prior to chemotherapy 66 patients had diffuse (extranodal) disease, 39 adenopathies above and below the diaphragm, and 13 adenopathies only above or below the diaphragm. 49/118 patients were pretreated with radiotherapy. The data were most complete for alkylating agents which were administered as a single agent in 93 patients. Complete remission (CR) plus partial remission (PR) greater than 50% occurred in 39% of patients with lymphocytic lymphoma, in 39% with histiocytic and in 50% with mixed type lymphoma (table 4). This type of response was observed with all drugs in 70% of nodular lymphomas and in 36% of diffuse lymphomas (table 7). The overall response rate to adriamycin was 75% in nodular lymphomas, and 55% in diffuse lymphomas. These data were 40% and respectively 14% after treatment with bleomycin. Median survival of all non-Hodgkin's lymphomas was 16.2 months (fig. 1); median survival was 23.4 months for nodular lymphomas and 17.4 months for diffuse lymphomas (fig. 2). Among nodular lymphomas, no significant differences were observed between nodular histiocytic and nodular lymphocytic well differentiated (fig. 3). Diffuse lymphocytic well differentiated lymphomas showed better survival in comparison to diffuse lymphocytic poorly differentiated, diffuse histiocytic and diffuse undifferentiated types (fig. 4). Patients responding to 2 drugs or more showed a better median survival (66 months) than those responding only to one drug (22.4 months) and unresponsive patients (10.2 months) (fig. 5). This study confirms most of the data reported by the Stanford group and emphasizes the need to employ a more deteailed histopathologic classification such as that proposed by Rappaport et al. Although this retrospective analysis has a number of drawbacks, it does provide, in terms of survival, a measurable indication that the responsiveness to at least two drugs is associated with better survival in non-Hodgkin's lymphomas than little or no responsiveness.

Gemcitabine as a Single Agent in the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

1999 ◽  
Vol 17 (12) ◽  
pp. 3786-3792 ◽  
Author(s):  
A. Fosså ◽  
A. Santoro ◽  
W. Hiddemann ◽  
L. Truemper ◽  
N. Niederle ◽  
...  
Keyword(s):  
Partial Response ◽  
Confidence Interval ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Single Agent ◽  
World Health ◽  
Hematologic Toxicity ◽  
Grade 3 ◽  
Health Organization ◽  
Hodgkin's Lymphomas

PURPOSE: A multicenter phase II trial was conducted to evaluate the efficacy and toxicity of gemcitabine in patients with relapsed or refractory aggressive non-Hodgkin's lymphomas (NHL). PATIENTS AND METHODS: Thirty-one patients with B-cell intermediate or high-grade NHL (Working Formulation) were enrolled onto the study. The median age was 61 years, with a Karnofsky performance status of ≤ 80% in 65% of patients. Forty-eight percent had stage III or IV (Ann Arbor Classification) at study entry. Pretreatment consisted of one, two, or three chemotherapeutic regimens in nine, 11, and 11 patients, respectively. Gemcitabine 1,250 mg/m2 was administered intravenously over 30 minutes on days 1, 8, and 15 of a 28-day schedule. RESULTS: Thirty patients were assessable for efficacy, and 31 were assessable for toxicity. No complete responses were observed, but six patients showed a partial response, 11 stable disease, and 13 progressive disease. The overall response rate was 20% (95% confidence interval, 8% to 39%) for assessable patients and 19% (95% confidence interval, 8% to 34%) for the intent-to-treat analysis. The median duration of partial response was 6 months (range, 3.7 to 15+ months). Nonhematologic World Health Organization grade 3 toxicity included hepatic toxicity in four patients and infection in two. Hematologic toxicity was observed as grade 3 anemia in three patients, grade 3 leukopenia in two patients, grade 3/4 neutropenia in two patients, and grade 3/4 thrombocytopenia in six patients. CONCLUSION: The present schedule of gemcitabine displays modest efficacy and mild toxicity in pretreated aggressive NHL.

Phase II single institution study of sequential biochemotherapy (BCT) for patients (pts) with stage IV melanoma (M)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8580-8580
Author(s):  
P. R. Bojanapally ◽  
D. T. Alexandrescu ◽  
V. Rusciano ◽  
P. H. Wiernik ◽  
J. P. Dutcher
Keyword(s):  
Median Survival ◽  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Stage Iv ◽  
Experimental Therapy ◽  
Ecog Performance Status ◽  
Maximum Benefit ◽  
Prospective Phase ◽  
Metastatic Sites

8580 Background: The utility of BCT for M remains controversial. A prospective phase II study was conducted to assess the clinical benefit of BCT in patients with stage IV M. Methods: Between March 2005 and March 2006 11 pts (6 Male and 5 Female with a median age of 54 (range 36 - 82)) with metastatic M were treated with paclitaxel 225 mg/m2 via continuous 24 hour IV infusion every 3 wks for 4 cycles or maximum benefit followed by HD IL2, 1.33 mg/m2 every 8 hours for 5 days of wk1 and wk3 based on pts tolerance to a maximum of 12 doses per wk. 2 Male pts received IL2 followed by paclitaxel. Pts had a ECOG performance status of 0 - 2, with a median time of 60 months since diagnosis of disease (range 7 to 240 months). 11 pts (92%) had multiple metastatic sites (50% had lung mets, 58% had liver mets) and 4 pts (33%) had prior chemotherapy or immunotherapy. Results: Of the 13 assessable pts one achieved a PR after paclitaxel and CR after IL2 continuing at 20+ months. One had SD for 1 year after receiving HD IL2 and SD for 6 months while on paclitaxel independently, One had PR for 6 months on paclitaxel and one had MR with paclitaxel for 3 months. 9 pts (69%) had PD on paclitaxel and again on IL2, with a median survival from treatment of 7 months, 2 of these got no IL2 due to rapid PD. An overall response rate of 30% (1 CR on paclitaxel + IL2 , 1 PR on paclitaxel, 2 SD (including MR) on paclitaxel) was seen with a median survival from treatment of 15 months. Conclusions: In this study there may be prolonged survival among responders, which may be due to synergy of sequential BCT, or may reflect single agent activity of each drug. BCT should still be considered as an experimental therapy and further evaluated. No significant financial relationships to disclose.

Retrospective analysis of sorafenib as first or second target therapy in mRCC patients in Italian centers: An update.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15524-e15524
Author(s):  
Lisa Derosa ◽  
Angela Gernone ◽  
Franco Morelli ◽  
Teodoro Sava ◽  
Fable Zustovich ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Retrospective Analysis ◽  
Target Therapy ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Complete Response ◽  
Daily Clinical Practice ◽  
Duration Of Treatment ◽  
Ecog Performance Status

e15524 Background: With several agents available for the treatment of metastatic renal cell carcinoma (mRCC) a better understanding of their use in daily clinical practice is fundamental in the decision-making process. Methods: The REtrospective analysis of Sorafenib (So) as 1st or 2nd targET therapy (RESET) in mRCC was a retrospective, observational field study that assessed the use and safety of So in clinical practice in Italian centers. Treatments were determined by physicians per local prescribing guidelines. Patients (pts) treated with So single agent as 1st or 2nd target therapy (TT) for mRCC between 1st Jan 2008 and 31st Dec 2010 were eligible for inclusion. Endpoints included safety, overall survival (OS), progression-free survival, response rate and treatment duration. Subgroup analyses included age, ECOG performance status, prior therapy, number of metastases and line of TT with So. Results: From Feb to Jul 2012, 358 pts from 37 Italian centers were enrolled. The most common ≥ grade 3 drug-related adverse events were hand-foot skin reaction (6.7%), rash (2.2%), hypertension, fatigue and diarrhea (1.7% each). In the overall population, median OS was 17.2 months (mos) (95% CI 15.4 – 19.6 mos) and median PFS was 5.9 mos (95% CI 4.9-6.7 mos). Median duration of treatment with So was 5.03 mos. Disease control (complete response + partial response + stable disease) was observed in 198(56%) pts. In pts receiving So as first or as second TT median OS was 19.9 mos (95% CI 15.9-25.3 mos) and 16.3 mos (95% CI 13.0-18.2 mos) respectively. In the subgroup of pts treated with So 1st TT followed by sunitinib (Su) 2nd TT (44 pts) and Su 1st TT followed by So 2nd TT (173 pts), median OS was 30.4 mos (95% CI 22.0-34.8 mos) and 16.6 mos (95% CI 13.1-18.2 mos) respectively. There were 269(76%) pts that received a total of 2 lines of therapy for mRCC, 133(38%) pts 3 lines and 43(12%) pts 4 lines of therapy. Conclusions: The efficacy and safety profile of So in the setting of Italian community-based daily clinical practice was similar to data reported in prospective clinical trials. The efficacy of So was observed in both the subgroups of pts receiving So as either the first or second TT for mRCC, with intriguing OS data in first line.

Phase II trial of panobinostat (LBH589) in patients (pts) with refractory metastatic colorectal cancer (MCRC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 582-582 ◽  
Author(s):  
Philip Jordan Gold ◽  
David A. Smith ◽  
Desiree Iriarte ◽  
Barry Boatman ◽  
Henry G. Kaplan
Keyword(s):  
Median Survival ◽  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Median Number ◽  
Open Label ◽  
Ecog Performance Status ◽  
Treatment Regimes ◽  
Open Label Phase ◽  
Secondary Endpoints

582 Background: LBH589 is a novel histone deacetylase inhibitor (HDACi) which induces apoptosis of tumor cells. LBH589 has been shown to cause regression of colon cancer in animal models and phase I trials have shown the agent to be well tolerated, providing rationale for studying this agent in pts with MCRC. Methods: This was a multicenter, open-label phase II study of single agent LBH589 in patients with MCRC who failed at least 2 prior regimens for metastatic disease. Measurable disease, adequate organ function and ECOG performance status of 0-2 were required. Pts received LBH589 30mg po on M/W/F until disease progression. Pts were evaluated for toxicity every 2 weeks and for response every 8 weeks. The primary endpoint was overall survival. Secondary endpoints included response rate, time to progression (TTP), and toxicity. Results: 29 pts were enrolled (16 male, 13 female). The median age was 59 (range 41-76). The median number of prior treatment regimes was 3 (2-11). The median survival was 5.1 months (range 1-24+). There were no objective responses. 3 pts had SD at 8 weeks. The median TTP was 7.7 weeks (range 1-38.). Six pts had grade 4 thrombocytopenia requiring platelet transfusion. Nine pts required dose reductions for toxicity. Conclusions: Single-agent LBH589 was not associated with objective tumor responses in this heavily pre-treated pt population. However, the median survival was comparable to that seen in other trials of single agent targeted therapy in the treatment of refractory MCRC. Thrombocytopenia was significant, and may complicate potential trials of combination therapy.

Response and Survival in Hodgkin's Disease after Sequential Chemotheraphy Employing a Single Agent.

1973 ◽  
Vol 59 (1) ◽  
pp. 45-56 ◽  
Author(s):  
Silvio Monfardini ◽  
Gabriele Tancini ◽  
Marco Gasparini ◽  
Gianni Bonadonna
Keyword(s):  
Median Survival ◽  
Hodgkin's Disease ◽  
Alkylating Agent ◽  
Main Sequence ◽  
Hodgkin’S Disease ◽  
Single Agent ◽  
Sequential Chemotherapy ◽  
Therapeutic Results ◽  
Duration Of Response ◽  
Advanced Hodgkin’S Disease

The therapeutic results obtained in 59 patients with advanced Hodgkin's disease treated from 1964 to 1969 with sequential chemotherapy employing a single agent are reported. The main sequence was alkylating agent first, vinblastine second and procarbazine third. Complete plus partial remission (> 50 %) ranged from a minimum of 37 % for patients treated with procarbazine to a maximum of 42 % for those given vinblastine. The median duration of response ranged from 4 to 5 months. Overall median survival from institution of chemotherapy was 24 months. Patients (26 cases) responding to 2 or more drugs showed a median survival of 40 months, which was statistically greater than that observed in an equal number of cases responding only to one drug (13 months) and than that of 7 patients unresponsive to all drugs (9 months). It is concluded from this retrospective study that survival in advanced Hodgkin's disease is longer in patients responding to at least two drugs that in patients responding less or not at all.

scholarly journals Increasing Karyotypic Complexity Predicts Outcomes in Patients with Chronic Lymphocytic Leukemia Treated with Ibrutinib

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 2-3
Author(s):  
Daniel Goldstein ◽  
Kyle A. Beckwith ◽  
Cecelia Miller ◽  
Ying Huang ◽  
Lynne V. Abruzzo ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Retrospective Analysis ◽  
Research Funding ◽  
Performance Status ◽  
Single Agent ◽  
Lymphocytic Leukemia ◽  
Complex Karyotype ◽  
Ecog Performance Status ◽  
Cytogenetic Abnormalities ◽  
Mutational Status

Introduction: Our group and others have previously shown that the presence of complex karyotype (>/= 3 cytogenetic abnormalities) is an important prognostic factor in relapsed/refractory (RR) chronic lymphocytic leukemia (CLL) patients treated with ibrutinib (Woyach JCO 2017, Thompson Cancer 2015, Maddocks JAMA Oncology 2015). It has been shown recently that increasing karyotypic complexity is a prognostic marker (Baliakis Blood 2019), but whether this is relevant for patients treated with novel therapies is unclear. Here, we aimed to determine whether the degree of karyotypic complexity beyond the dichotomy of complex versus not is a prognostic variable for patients with CLL treated with ibrutinib. Methods: We conducted a retrospective analysis of all patients with CLL treated with ibrutinib as a single agent or in combination with a monoclonal anti-CD20 antibody (MOAB) from 2010 through 2019 at The Ohio State University. We included patients with both treatment-naïve (TN) and RR disease. To determine karyotype, cells were stimulated with mitogen cocktail (PWM/PMA/CpG-ODN) and analyzed according to standard laboratory procedures. FISH using probes for D13S319, D12Z3, ATM, and TP53 were done according to manufacturer's recommendations. PCR was used to determine IGHV mutational status. Cytogenetic testing was included in the analysis if done <6 months before or within 60 days after ibrutinib initiation. All characteristics were measured at ibrutinib start. Multivariable Cox proportional hazards models were built to correlate karyotypic complexity (defined as a continuous variable with 1 unit increases) with progression free survival (PFS) and overall survival (OS), adjusted for age, RR status, ECOG performance status (PS), lactate dehydrogenase (LDH), white blood cell (WBC) count, hemoglobin (HgB), platelet (PLT) count, presence of del17p13 and IGHV mutational status. Multivariable models were fit in imputed datasets, and estimates were obtained from combining results from across 30 imputed datasets. Results: We analyzed 561 patients with a median age of 65 (range 26-91). 86% were treated with ibrutinib monotherapy, 22% were TN, and median number of prior therapies was 2 (range 0-13). 96% had an ECOG performance status (PS) of 0 or 1. Median LDH, WBC, HgB and PLT were 213 U/L, 23.2 K/uL, 11.2 g/dL, and 115 K/uL respectively. With available data, del13q14, trisomy 12, del11q22, and del17p13 was present in 50%, 22%, 30%, and 29% of patients respectively; 74% of patients were IGHV unmutated. 63 patients were excluded from cytogenetic analyses as the test was not done during the specified time window. Of the 458 evaluable, 50% had >3 cytogenetic abnormalities including 30% with >5 abnormalities. After a median follow up of 55.5 months, for the entire cohort estimated median PFS was 61.6 months (95% CI 56.1-69.5), and estimated median OS was 95.4 months (95% CI 86.3-not reached). On univariable analysis, older age, RR status, higher ECOG PS and LDH, lower HgB and PLT, presence of del17p13 and increasing karyotypic complexity were found to be statistically significant predictors of worse PFS and OS. To illustrate the relationship between increasing karyotypic complexity and clinical outcome, Kaplan-Meier plots are provided grouping pts with 0-2, 3-4, and 5 or higher aberrations (Figure 1). Accounting for statistically and clinically important factors on multivariate analysis (MVA, Table 1), increasing karyotypic complexity continued to be a statistically significant predictor of both PFS (p=0.01, HR 1.08 (95% CI 1.02-1.15)) and OS (p=0.001, HR 1.14 (95% CI 1.05-1.23)). Del17p13 did not retain statistical significance independently of karyotypic complexity on MVA. The interaction effect between prior treatment status and karyotypic complexity term was not significant for OS (p=0.89) and PFS (p=0.46), suggesting the prognostic effect of karyotypic complexity is similar across TN and RR cohorts. Conclusions: In this single center retrospective analysis, we found that increasing karyotypic complexity predicts inferior survival for patients with CLL treated with ibrutinib. This highlights that it is not only important to dichotomize presence of complex karyotype as >3 abnormalities, but to describe the number of karyotypic abnormalities in subsequent studies. Disclosures Bond: Seattle Genetics: Honoraria. Byrd:Acerta Pharma: Research Funding; Trillium: Research Funding; Pharmacyclics LLC, an AbbVie Company, Janssen, Novartis, Gilead, TG Therapeutics: Other; Pharmacyclics LLC, an AbbVie Company, Gilead, TG Therapeutics, Novartis, Janssen: Speakers Bureau; Pharmacyclics LLC, an AbbVie Company, Gilead, TG Therapeutics, BeiGene: Research Funding; Janssen: Consultancy; Leukemia and Lymphoma Society: Other; Novartis: Research Funding; Kartos Therapeutics: Research Funding; Vincera: Research Funding; Syndax: Research Funding. Rogers:AstraZeneca: Other: Travel; Abbvie, Acerta, AstraZeneca, Pharmacyclics: Consultancy; Abbvie, Genetech, Janssen: Research Funding. Woyach:Pharmacyclics: Consultancy, Research Funding; AbbVie: Research Funding; Janssen: Consultancy, Research Funding; Karyopharm: Research Funding; Morphosys: Research Funding; Loxo: Research Funding; Verastem: Research Funding.

Supportive care and chemotherapy (CT) versus supportive care alone in advanced non-small cell lung cancer (NSCLC): A meta-analysis using individual patient data (IPD) from randomised clinical trials (RCTs)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7582-7582 ◽  
Author(s):  
S. Burdett ◽  
L. A. Stewart ◽  
J. F. Tierney ◽  
C. Le Pechoux
Keyword(s):  
Supportive Care ◽  
Meta Analysis ◽  
Alkylating Agents ◽  
Performance Status ◽  
Single Agent ◽  
Rank Test ◽  
Absolute Benefit ◽  
Absolute Effect ◽  
The Absolute ◽  
Treatment Comparisons

7582 Background: Building on a previous IPD meta-analysis of CT (BMJ 1995;311:899–909) which suggested that CT may have a role in the treatment of NSCLC, we have carried out a new, up-to-date IPD meta-analysis. This includes RCTs, regimens and outcomes that were not available in 1995. This new meta-analysis examines the role of CT in 7 treatment comparisons. Here we report the effectiveness of supportive care plus CT compared with supportive care alone. Methods: We conducted a systematic search for RCTs followed by the central collection, checking and re-analysis of updated IPD. Results from individual RCTs were combined using the stratified (by trial) log rank test to calculate individual and pooled hazard ratios (HRs). Previously included RCTs using long-term alkylating agents were excluded from this analysis due to their antiquity. Results: IPD were obtained on 2,666 patients from 15 RCTs. 11 RCTs used cisplatin-based CT regimens, 4 RCTs used single agent CT (etoposide, navelbine, gemcitabine, paclitaxel). This added 6 RCTs and 1,702 patients to the 1995 analyses. The results show a highly significant benefit of CT on survival (HR=0.78 95% Confidence Interval 0.71–0.84, p<0.000001), with an absolute benefit of 8% (from 20% to 28%) at 12 months across all patients. There was no evidence of a difference in effect (p=0.69) between trials that used cisplatin-based regimens (11 RCTs, HR=0.76), etoposide alone (1 RCT, HR=0.87) or newer single agents (3 RCTs, HR=0.79) (Interaction p=0.69). There was no evidence that any patient subgroup defined by age, sex, stage or histology benefited more or less from CT. The absolute benefit of CT at 12 months did vary according to WHO/ECOG (or equivalent) performance status. PS 0=8% (from 26% to 34%), PS 1=8% (from 18% to 26%), PS 2=5% (from 6% to 11%) and PS 3=4% (from 5% to 9%). Conclusion: The results demonstrate a substantial and consistent relative benefit of CT in advanced NSCLC. The effectiveness of newer agents such as navelbine, paclitaxel and gemcitabine (used as single agents) appears to be similar to that of cisplatin combined with older agents such as vindesine and mitomycin C. The absolute effect of CT varied according to performance status. No significant financial relationships to disclose.

Erlotinib as initial therapy in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2: A SWOG phase II trial (S0341)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7536-7536 ◽  
Author(s):  
P. J. Hesketh ◽  
K. Chansky ◽  
A. J. Wozniak ◽  
P. Mack ◽  
P. N. Lara ◽  
...  
Keyword(s):  
Median Survival ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Kinase Inhibitor ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Single Agent ◽  
Stage Iiib ◽  
Gene Copy ◽  
Egfr Expression

7536 Background: Patients (pts) with advanced NSCLC and PS 2 have an inferior survival compared with good PS pts. Single agent and combination chemotherapy have been used with modest success with toxicity often limiting treatment. Targeted agents such as the EGFR tyrosine kinase inhibitor erlotinib (E) offer an alternative which may confer comparable benefit with better tolerance. This phase II trial of E in unselected chemotherapy-naive pts with advanced NSCLC and PS 2 was performed to obtain preliminary data regarding efficacy and EGFR biology in this pt population, and to set the stage for a subsequent randomized trial of E vs.chemotherapy, in pts selected for EGFR expression. Methods: Eligibility: stage IIIB (pleural effusion)/IV NSCLC; measurable disease; PS 2; no prior chemotherapy/biologic treatment for NSCLC. Treatment: E 150 mg orally daily. Molecular correlative studies:EGFR protein expression (IHC), gene copy (FISH), mutation analysis. Results: Pts: 82; 73 eligible; 72 fully evaluable; age (median) 74.4; M/F 47%/53%; current/former smoker 91%; stage IIIB/V 12%/88%; adenoca 54%. Treatment was well tolerated. Five pts (7%) had a grade 4 toxicity (fatigue 3 pts; dyspnea 2 pts). Most common grade 3 toxicities: fatigue 9 pts (13%); rash 7 pts (10%); diarrhea 5 pts (7%); anorexia 5 pts (7%). There was 1 possible treatment related death due to pneumonitis. One complete (1%) and 5 (7%) partial responses were noted. Stable disease was seen in 25 pts (35%) for an overall disease control rate (DCR) of 43% (31 pts). Progression free survival: 2.1 months (95% CI 1.5 –3.1); Median survival: 5.0 months (95 % CI 3.5 –7.3). One year survival: 22% (95% CI 12 –32%). Analysis of molecular correlates is ongoing. Conclusions: Single agent erlotinib is a well tolerated treatment for chemotherapy- naive patients with advanced NSCLC and PS 2 with an overall DCR of 43% and median survival of 5 months. These efficacy results are comparable to the outcome seen in SWOG trial S0027 in PS 2 pts employing sequential vinorelbine and docetaxel. We hypothesize that pt selection by an EGFR biomarker strategy will improve results with E, and that E will be superior to chemotherapy in this selected population.This trial design is under development within SWOG at present. [Table: see text]

Retrospective analysis of sorafenib as first- or second-line targeted therapy in patients with mRCC: Three-year Italian experience.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 415-415
Author(s):  
Giuseppe Procopio ◽  
Lisa Derosa ◽  
Angela Gernone ◽  
Franco Morelli ◽  
Teodoro Sava ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Retrospective Analysis ◽  
Group Performance ◽  
Target Therapy ◽  
Performance Status ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Duration Of Treatment ◽  
Community Based

415 Background: The Retrospective analysis of Sorafenib (So) as the first- or second- target therapy (RESET) study in metastatic renal cell carcinoma (mRCC) patients assessed the use and safety of sorafenib under daily-life treatment conditions in a community-based patient population in Italian centers. Methods: RESET was a retrospective, observational, non-interventional field study in mRCC patients. Treatment decisions were determined by each physician according to local prescribing guidelines and clinical practice. Patients for whom a decision to treat with sorafenib single agent as first- or second- target therapy (TT) for mRCC has been made, were eligible for inclusion. Patients that started So treatment between January 1, 2008 and December 31, 2010 were included. Data collection started retrospectively in 2012, in order to have a period of observation of at least 1 year up to 31st Dec 2011. Endpoints included safety, overall survival (OS), progression-free survival (PFS), response rate (RR), and treatment duration. Subgroup analyses included age, Eastern Cooperative Oncology Group performance status, prior therapy, number of metastases, and line of TT with So. Results: From February to Jululy 2012, 358 pts from 37 Italian centers were enrolled. The most common ≥ grade 3 drug-related adverse events were hand-foot skin reaction (6.3%), rash (2.3%), hypertension, fatigue, and diarrhea (1.7% each). In the overall population, median OS was 17.2 months (mos) (95% CI 15.5 – 19.6 mos) and median PFS was 5.9 mos (95% CI 5.0-6.8 mos). Median duration of treatment with So was 5.09 mos. Complete response was observed in 3 (0.8%) pts, partial response in 53(15.0%) pts and stable disease in 139(39.4%) pts. In pts receiving So as first- or second- TT, median OS was 19.9 mos (95% CI 15.4-25.3 mos) and 16.6 mos (95% CI 13.1-18.4 mos) respectively, and median PFS was 6.6 mos (95% CI 4.9-9.3 mos) and 5.3 mos (95% CI 4.4-6.2 mos) respectively. Conclusions: The efficacy and safety of So under routine clinical practice conditions in the setting of community-based practice in Italy were similar to that reported in prospective clinical trials. The efficacy of So was observed in the subgroup of pts receiving So as either the first or second TT for mRCC.

Phase II study of concurrent temozolomide and whole brain radiation therapy in patients with brain metastasis

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1540-1540 ◽  
Author(s):  
S. Dawood ◽  
J. Ragaz ◽  
S. Navaratnam ◽  
C. Mihalcioiu
Keyword(s):  
Lung Cancer ◽  
Brain Metastases ◽  
Median Survival ◽  
Systemic Disease ◽  
Performance Status ◽  
Single Agent ◽  
End Points ◽  
Status Score ◽  
Moderate Nausea ◽  
Single Agent Chemotherapy

1540 Background: 30% of patients (pts) with lung cancer develop brain metastases, with XRT representing the conventional treatment of multiple BM. Methods: Pts with lung cancer, Brain metastases (BM) and performance status of 0–2 were enrolled. TMZ (75mg/m2 day 1–14) given on cycle 1 with XRT (3000cGy in 10 fractions) followed by cycles 2–4 TMZ (200mg/m2 day 1–5, q 4 weeks). Pts with active systemic disease received also chemotherapy (cisplatin or docetaxel or paclitaxel) during TMZ cycles 2–4. Primary end points: 1. Radiological response of BM assessed after 4–6 weeks from the end of XRT, 2. Treatment related toxicity, 3.Functional Scale score(FSS)(1 best, 3 worst, based on interaction of WHO performance status, score 0–4, with the neurological status score 1–3). FSS was assessed at baseline, and during the follow up visits. Secondary end points: time to progression and overall survival. Results: 22 patients enrolled, 8 pts received TMZ alone and 14 pts had additional chemotherapy. CR was documented in 2 pts, PR in 6 pts, SD in 5 pts, 4 pts progressed on treatment; 5 pts were not evaluable (death from other causes within 2 months from diagnoses). FSS at baseline was available on 19/22 patients. Of those, thirteen, four and two pts had a FSS of 1, 2 and 3, respectively. Fifteen of the 19 pts maintained their FSS at the end of Tx, with 3 pts exhibiting deterioration, and one patient improved. Post treatment FSS remained stable in 16 patients up to one month prior to death. The median survival (22 pts) from the time of diagnosis of BM was 9 months with average TTP of 3.5 months. Except for moderate nausea and vomiting there was no significant toxicity by combining TMZ with XRT. The addition of single agent chemotherapy to TMZ was well tolerated but two patients who required GCSF support. Conclusion: Adding TMZ to XRT for the treatment of BM from in lung cancer patients showed a response in 13 out of 17 assessable patients with a median survival of 9 months which is above the mean 3 to 6 months survival reported in the literature with XRT alone. More importantly, the majority of patients maintained a stable FSS up to one month prior to death suggesting a quality of life benefit during most of their life span. TMZ can be safely administered concomitantly with either XRT or with other single agent chemotherapy. No significant financial relationships to disclose.

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