Personalized ANtibodies for GastroEsophageal Adenocarcinoma (PANGEA): Primary efficacy analysis of the phase II platform trial (NCT02213289).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 356-356 ◽  
Author(s):  
Daniel V.T. Catenacci ◽  
Samantha Lomnicki ◽  
Leah Chase ◽  
Bryan Peterson ◽  
Kelly Moore ◽  
...  
Keyword(s):  
Randomized Study ◽  
National Institutes Of Health ◽  
Molecular Heterogeneity ◽  
Peritoneal Disease ◽  
Efficacy Analysis ◽  
Gastroesophageal Adenocarcinoma ◽  
Ecog Ps ◽  
Level 2 ◽  
Clinical Trial Information ◽  
Primary Efficacy Analysis

356 Background: 1-yr OS is ~40% for HER2- & ~55% for HER2+ advanced (aGEA). Targeted therapies (tx) have had limited benefit due to molecular heterogeneity. Methods: This phase 2a study of a personalized tx strategy (PTS) enrolled newly diagnosed aGEA pts who then received up to 3 cytotoxic (cx) lines: first line (1L) 5FU + oxaliplatin, 2L 5FU + irinotecan & 3L 5FU + docetaxel. Baseline biomarker profiling (BP) was mandated on primary & metastatic tumors (PT/MT) & progressive disease points (PD1, PD2). Assigned antibody (AN) was added to cx by a predefined prioritized tx algorithm (PTA) (Table) based on the MT BP. At PD1, pts went to 2L cx + initial AN. Upon results of PD1 BP, pts changed AN only if BP evolved per PTA. The same was done at PD2. If AN was unavailable (MET/FGFR2), these pts were tx’d with cx alone (not ITT). The 10 endpt was 1-yr OS of the PTS. Assuming historical 50% 1-yr OS for all aGEA pts, 68 pts tx’d per protocol PTS provided 80% power to detect an HR=0.67, corresponding to a 1-yr OS rate of 63% (under exponential survival), using a 1-sided test at the 0.10 alpha level. 20 endpts: safety, feasibility, PT/MT BP discordance at baseline & over tx line, & OS/PFS/ORR by tx line & BP group. Results: Between 6/2015-5/2019, 80 consecutive pts enrolled at 3 sites: ECOG PS 0-2 40/33/7; Male 80%; median age 60, range 28-81, peritoneal disease 36%. AN assigned by PTA at 1L & 1-yr OS are shown (Table). PT/MT discordance was 37%. Of 68 pts treated by PTS ITT, the 1-yr OS was 69.4% (p<0.001). The mOS was 16.4m [95%CI 13.8-20.8]. Any grade >3 tox thru all 3 tx lines was seen in 32% of pts. 20 analyses will be presented. Conclusions: PANGEA was feasible & met its 10 efficacy objective with observed 1-yr OS of 69.4%, meriting a randomized study. Clinical trial information: NCT02213289 . U.S. National Institutes of Health.[Table: see text]

Personalized antibodies for gastroesophageal adenocarcinoma (PANGEA): Secondary and final primary efficacy analyses.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4561-4561
Author(s):  
Daniel V.T. Catenacci ◽  
Bryan Peterson ◽  
Leah Chase ◽  
Samantha Lomnicki ◽  
Anthony Serritella ◽  
...  
Keyword(s):  
Progressive Disease ◽  
Metastatic Tumor ◽  
Molecular Heterogeneity ◽  
Primary Efficacy ◽  
Newly Diagnosed ◽  
Molecular Subgroup ◽  
Gastroesophageal Adenocarcinoma ◽  
Ctdna Analysis ◽  
Tissue Biomarker ◽  
Clinical Trial Information

4561 Background: Targeted therapies (tx) have had limited benefit in advanced (aGEA) due to baseline spatial (primary vs metastatic tumor PT/MT) & temporal molecular heterogeneity (BMH/TMH). We previously reported PANGEA methods & results: 35% BMH rate & 10 OS results achieving 1yr OS of 66% & mOS of 16.4 months (m) using the personalized tx strategy (Catenacci et al. GI ASCO 2020 Abstr356). Here we will report the TMH rates at progressive disease points (PD1 & PD2), ORR/PFS/DCR in each of 3 tx lines, time to strategy failure (TTF), & updated OS/safety. Methods: PANGEA enrolled newly diagnosed aGEA pts who then received up to 3 cytotoxic (cx) tx lines (L). Baseline tissue biomarker profiling (BP) was mandated on PT/MT & PD1/PD2, & ctDNA analysis throughout. After initiating 1L cx & upon learning MT BP results, antibody (AN) was added by a predefined prioritized tx algorithm incorporating tissue & blood BP (Table). At PD1, pts went to 2L cx + initial AN. Upon results of PD1 BP, pts changed AN only if BP evolved per tx algorithm. The same was done at PD2. The 10 endpoint was 1yr OS; enrolling 68 pts provided 80% power to detect a 63% 1yr OS compared to historical 50% 1yr OS (HR 0.67), using a 1-sided test (0.10 alpha). Results: 80 pts were enrolled, & 68 tx’d per protocol. At data cut-off 2/1/20, 15 pts were still on trial with only 2 of these pts on tx <12m (8 pts in 1L, 5 in 2L, 2 in 3L). All 68 pts had at least 1 dose of 1L tx, 87% 2L tx, & 36% 3L tx. AN assigned by the tx algorithm at 1L, OS, TTF, & ORR1/PFS1/DCR1 of 1L tx are shown in Table; 2L & 3L ORR/DCR outcomes will be shown. The 3yr & 4yr OS rates were 12% & 8%. TMH leading to molecular subgroup change by tx algorithm was 51% after 1L & 36% after 2L; details & results by subgroup will be provided. Any grade >3 non-heme tox thru all 3 tx lines was seen in 25% of pts. Conclusions: PANGEA showed superior 10 & 20 endpoint efficacy, even when excluding HER2- pts, compared to historical outcomes. Clinical trial information: NCT02213289 . [Table: see text]

Phase II trial of miniDOX (reduced-dose docetaxel/oxaliplatin/capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC): TTD 08-02.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 87-87 ◽  
Author(s):  
Fernando Rivera ◽  
Bartomeu Massuti ◽  
Matilde Salcedo ◽  
Javier Sastre ◽  
Joaquina Martínez-Galán ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Progression Free Survival ◽  
Free Survival ◽  
Efficacy Analysis ◽  
Hand Foot Syndrome ◽  
Level 1 ◽  
Grade 3 ◽  
Level 2 ◽  
Clinical Trial Information

87 Background: Chemotherapy has improved overall survival (OS) in patients (p) with AGC and docetaxel (D), oxaliplatin (O) and capecitabine (X), have shown consistent activity in this setting. We defined "Suboptimal" p as those with PS ECOG-2 and/or weight loss 10-25% and/or age ≥70 years. This population is usually underrepresented in AGC clinical trials. Methods: We explored in 43 previously untreated "suboptimal" AGC p the "miniDOX" regimen (D: 40 mg/m2 iv, d1; O: 80 mg/m2 iv d1; C: 625 mg/m2 po bid, d1 to 21, every 21d; after 6 courses only C was maintained). D and O dose were allowed to be increased to 45 and 90 mg/m2 respectively (dose level +1) and to 50 and 100 mg/m2 (level +2) if less than grade 2 toxicity after the first 2 courses. One p that did not received any dose of chemotherapy, was included in the ITT efficacy analysis but not in the safety analysis. Primary endpoint was Response Rate (RR), Toxicity, Progression Free Survival (PFS) and OS were secondary objectives. Results: p characteristics: PS ECOG-2:12 p, Weigh loss 10-25%:23 p; median age 73.3 years (40-87); 32 males; locally advanced:8 p/metastatic:35 p; Primary site:Gastric 32 p/ EGJ 11; In 19 p the dose of D and O were increased to level +1 and in 8 of them to level +2. Worst toxicity per p (Grade 3-4): neutropenia: 5 p (3 of them with febrile neutropenia); pulmonary embolism (PE):4 p (3 of them suffered sudden death and the PE was suspected but not confirmed); diarrhea:9 p; paronychia:2 p; CVA:1 p; renal failure:1 p (this p suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome:4 p and asthenia:5 p. Response: CR:1 p, PR:23 p (RR: 56%), SD:12 p, Progression:3 p, No determined:4 p; With a median follow-up of 27 months, 36 p have died (toxicity:4 p, progressive disease:32 p). Median and 1 year actuarial PFS and OS are 5.5 months/19% and 13.3 months/54% respectively. Conclusions: Although relevant the toxicity of miniDOX has been found, its activity is encouraging in "suboptimal" pts with AGC and this combination should be further investigated in this setting. Clinical trial information: NCT00733616.

First-MIND: A phase Ib, open-label, randomized study to assess safety of tafasitamab (tafa) or tafa + lenalidomide (LEN) in addition to R-CHOP in patients with newly diagnosed DLBCL.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7540-7540
Author(s):  
David Belada ◽  
Katerina Kopeckova ◽  
Juan Miguel Bergua ◽  
Marc André ◽  
Ernesto Perez Persona ◽  
...  
Keyword(s):  
Performance Status ◽  
Randomized Study ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Dose Intensity ◽  
Newly Diagnosed ◽  
Open Label ◽  
Bulky Disease ◽  
Phase Ib ◽  
Ecog Ps

7540 Background: Tafasitamab is a humanized, Fc-modified anti-CD19 monoclonal antibody that enhances antibody-dependent cellular cytotoxicity and phagocytosis. It is FDA-approved with LEN for adult patients (pts) with relapsed/refractory (R/R) DLBCL ineligible for autologous stem cell transplantation. First-MIND (NCT04134936) is a Phase Ib, open-label, randomized study of tafa + R-CHOP or tafa + LEN + R-CHOP in newly diagnosed DLBCL. Methods: Eligible pts were ≥18 years, treatment-naïve, with histologically confirmed DLBCL not otherwise specified, international prognostic index (IPI) 2–5 and ECOG performance status (PS) 0–2. Pts with known double- or triple-hit and transformed lymphoma were excluded. Treatment (Tx) comprised six 21-day cycles of tafa (12 mg/kg IV, Day [D] 1, 8, 15) + R-CHOP (arm A) or tafa (12 mg/kg IV, D1, 8, 15) + LEN (25 mg orally, D1–10) + R-CHOP (arm B). G-CSF and VTE prophylaxis was mandatory. Primary objective is safety; secondary objectives are ORR, PET-CR rate at end of Tx, PFS, long-term safety, pharmacokinetics, immunogenicity. Results: From Dec 2019 to Aug 2020, 83 pts were screened in Europe and the US; 66 were randomized (33 per arm). Data cut-off for this analysis: 9 Dec 2020; study is ongoing. Median age was 64.5 years (range 20–86). Overall, 30% (20/66) of pts were ≥70 years and many had high-risk disease: IPI 2 29%, IPI 3 46%, IPI 4 26%. ECOG PS: 47% of pts were ECOG PS 0, 44% PS 1, 9% PS 2. Most pts had stage III/IV disease (92%); 46% had bulky disease. All pts experienced a treatment-emergent adverse event (TEAE). Grade ≥3 neutropenia and thrombocytopenia occurred in 54.5% and 12.1% (arm A) and 66.7% and 30.3% (arm B) of pts, respectively (Table). Serious TEAEs occurred in 42.4% (arm A) and 51.5% (arm B) of pts. There were three deaths, unrelated to tafa and/or LEN (sepsis, urosepsis, and COVID-19 pneumonia). R-CHOP dose intensity was maintained in both arms. Among 60 pts who completed tumor assessments after cycle 3, ORR was 89.7% (arm A) and 93.5% (arm B). Conclusions: These data suggest R-CHOP + tafa or tafa + LEN is tolerable in pts with Tx-naïve DLBCL and that R-CHOP dosing is not affected. Toxicities are similar to those expected with R-CHOP or R-CHOP + LEN. Updated safety and early efficacy data will be presented at the conference. Clinical trial information: NCT04134936. [Table: see text]

Stentless hypospadias repair: The way forward

2020 ◽  
pp. 205141582093126
Author(s):  
Gursev Sandlas ◽  
Charu Tiwari ◽  
Jyoti Bothra ◽  
Bhushan Jadhav ◽  
Hemanshi Shah
Keyword(s):  
Randomized Study ◽  
Surgical Site Infections ◽  
Slight Modification ◽  
Standard Of Care ◽  
Hypospadias Repair ◽  
Level Of Evidence ◽  
Tubularized Incised Plate ◽  
Age At Surgery ◽  
Level 2

Background: Stentless repair of hypospadias has been previously described in the literature for distal penile hypospadias repair. This was a prospective non-randomized study with the aim of assessing the efficacy of stentless repair in our health-care system. Methods: A total of 104 patients managed prospectively for hypospadias over a 30-month period who met the inclusion criteria were included in the study and underwent a stentless modified tubularized incised plate (TIP) urethroplasty repair (with a slight modification described subsequently) by three surgeons and were followed up for a minimum period of six months. Results: The median age at surgery was eight months. The site of meatus was glanular in 20 patients, coronal in 36 patients, sub-coronal in 38 patients and mid-penile in 10 patients. The median operative time was 47 minutes (range 32–76 minutes). The median time to first micturition was 140 minutes (range 10–300 minutes). Voiding difficulty was encountered in two patients, requiring catheterization. Three patients had superficial surgical site infections which were conservatively managed. All patients were discharged on the second postoperative day, except for the three patients with surgical site infection. On follow-up, two patients had a fistula. Conclusion: Stentless repair of hypospadias is the future and the new standard of care and should be used in every case where a modified TIP repair is feasible. This decreases complications from urethral stenting and decreases the duration of hospital stay. Both patient and parents are comfortable with this procedure. Level of evidence Level 2.

The Effects of Unfractionated Heparin on Survival in Patients with Malignancy – A Systematic Review

1999 ◽  
Vol 82 (12) ◽  
pp. 1600-1604 ◽  
Author(s):  
Rohan Hettiarachchi ◽  
Roel Vink ◽  
Harry Büller ◽  
Susanne Smorenburg
Keyword(s):  
Unfractionated Heparin ◽  
Gastrointestinal Cancer ◽  
Small Cell Lung Carcinoma ◽  
Randomized Study ◽  
Experimental Studies ◽  
Convincing Evidence ◽  
Cell Lung Carcinoma ◽  
Level 2 ◽  
Methodological Strength ◽  
Heart Foundation

SummaryClinical and experimental studies have suggested that unfractionated heparin (UFH) effects malignancy progression. We reviewed all published clinical reports concerning the effects of UFH, as compared to no treatment on survival of cancer patients. Studies were classified on methodological strength and subdivided as to whether therapeutic or prophylactic dosages of UFH were used. Mortality rates after 3 years were extracted or calculated. One randomized study that evaluated the use of UFH in therapeutic dosages in patients with small cell lung carcinoma reported on an improved survival (odds ratio (OR) 0.64; 95% confidence interval (CI): 0.25 to 1.62). A detrimental effect was observed in 2 randomized studies which investigated the effects of intraportal UFH treatment in a prophylactic dose after surgery for gastrointestinal cancer (OR 1.66; 95% CI: 1.02 to 2.71). In contrast, level 2 studies in which either therapeutic or prophylactic dosages of UFH on mortality of patients with gastrointestinal cancer were evaluated, showed OR of 0.58 (95% CI; 0.11-3.13) and 0.65 (95% CI 0.51 to 0.84), respectively. We conclude that there is no convincing evidence of either positively or negatively effects of UFH on survival of patients with malignancy.Harry R. Büller is an Established Investigator of the Dutch Heart Foundation

Update of the FL2000 randomized trial combining rituximab to CHVP-Interferon in follicular lymphoma (FL) patients (pts)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7508-7508 ◽  
Author(s):  
C. Foussard ◽  
N. Mounier ◽  
A. Van Hoof ◽  
V. Delwail ◽  
O. Casasnovas ◽  
...  
Keyword(s):  
Overall Survival ◽  
Randomized Study ◽  
Bone Marrow Involvement ◽  
Risk Groups ◽  
Tumor Burden ◽  
Event Free Survival ◽  
Free Survival ◽  
High Tumor Burden ◽  
Ecog Ps

7508 Background: The GELA-GOELAMS FL2000 trial investigated the role of rituximab in the first line treatment of FL pts. Methods: This prospective randomized study compared the CHVP regimen (12 courses) +18 months α2b-IFN (CHVP-I) to 6 CHVP courses combined with 6 rituximab infusions + 18 months IFN (R-CHVP-I). The primary endpoint was event-free survival (EFS). Inclusion criteria consisted in untreated stage II-IV FL pts; 18–75 years old; with a high tumor burden defined by at least one of the following criteria: B symptoms, ECOG PS>1, LDH>normal value, β2-microglobulin ≥3 mg/L, largest tumor ≥7 cm, 3 distinct nodes ≥3 cm, serous effusion, compression or symptomatic spleen enlargement. Results: From 05/00 until 05/02, 358 eligible pts were randomized (CHVP-I 183 pts and R-CHVP-I 175 pts) with the following characteristics: M/F = 1; median age = 60 years [25–75]; ECOG > 1 = 8%; B symptoms = 27%; AA stage > II = 87%; bone marrow involvement = 58%; β2-m ≥3 mg/L = 31%; LDH > N = 37%; Hb <12 g/dL = 18%; FLIPI score ≥3 in 57% of the pts. The first analysis [ASH 2004] showed a significant better treatment response in R-CHVP-I as compared to CHVP-I and a improvement of event free survival (EFS) in the R-CHVP-I arm (Log-Rang, P = .003). As initially planned, a second analysis on all pts has now been performed with a median follow-up of 3½ years, all pts with data >01/01/05. The median EFS for the whole population has not yet been reached. In the CHVP-I arm, median EFS was 3 years and 46% of the pts are event-free at 42 months (mo.). In contrast, the median has not been reached in the R-CHVP-I arm and the EFS is 67% at 42 mo. (P < .0001). This improvement in EFS was found both in the 150 pts with a low or intermediate FLIPI score (P = .019) and in those (n = 201) with a high score (P = .0005). When considering the 230 pts responders at the end of 18 mo. of therapy, 42 mo. EFS is 62% in CHVP-I arm versus 81% in R-CHVP-I arm (P = .002). Finally, the overall survival at 42 mo. of patients in the CHVP-I arm is of 84% versus to 91% in the R-CHVP-I arm (P = .029) with a reduction of death risk by approximately 2 (RR = 0.55). Conclusions: These results demonstrate that rituximab combined with CHVP-I has a durable benefit, in all FLIPI risk groups, allows to reduce the duration of chemotherapy and improves overall survival in high-tumor burden FL pts. [Table: see text]

A phase I dose-escalating study of combination S-1 and carboplatin (CBDCA) in patients with chemo-naïve advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17055-17055
Author(s):  
K. Tamura ◽  
I. Okamoto ◽  
T. Ozaki ◽  
T. Shimizu ◽  
T. Kashii ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Objective Response ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Eligibility Criteria ◽  
Level 3 ◽  
Adequate Organ Function ◽  
Level 1 ◽  
Ecog Ps ◽  
Level 2

17055 Background: S1, a novel oral fluoropyrimidine derivative, has promising results in the treatment of advanced gastric or colorectal carcinoma. Response rate/median survival time of single S1 and the combination S1 plus cisplatin for advanced NSCLC were 22.0%/309 days and 47.3%/335 days, respectively in the previous phase II. Platinum doublets including a novel active drug is a potent standard for advanced NSCLC as 1st line chemotherapy. Carboplatin has advantage of low gastrointestinal or renal dysfunction in comparison with cisplatin. The primary objective of this study was to determine the maximum tolerated dose (MTD) of combination S-1 and carboplatin, the toxicity profile and the recommend dose (RD) for a multi-center randomized trial of platinum doublets including S1. Methods: Eligibility criteria includes histologically diagnosed NSCLC stage IIIB/IV, no prior chemotherapy, ECOG PS 0–1, 75 > age >20, adequate organ function, and written informed consent. Pts receive carboplatin intravenously over 30 minutes on day 1, and S1 daily for 2 weeks, every 3 weeks. Results: Total 10 patients were registered (M/F: 6/4; median age:67 (37–73); Ad/Sq:7/3; IIIB/IV: 0/10 PS 0/1:3/7) Three patients were enrolled at the dose level 1 (CBDCA AUC = 5 and S1 65 mg/m2), 3 patients at level 2 (CBDCA AUC=5 and S1 80 mg/m2) and 4 patients at level 3 (CBDCA AUC=6 and S1 80 mg/m2), respectively. No DLTs (dose-limiting toxicities) occurred at both level 1 and 2. DLTs were observed in 2 out of 4 patients at level 3. One is significant delay starting of 2nd cycle caused by thrombocytopenia. One is G3 anorexia and vomiting at 1st cycle and results in stop the treatment. A total 27 courses were assessable for safety. Two pts with G3 neutropenia, 2 pts with G3 anorexia, 1 pts with G3 liver dysfunction and 1 pts with G3 infection were observed during total courses. Five out of 6 patients at Level 1 or 2 have completion of 4 cycle’s treatment. Objective response was obtained in three patients out of 10. Conclusions: MTD was level 3. RD for the future trial was Level 2 (CBDCA AUC = 5 and S1 80 mg/m2). This combination was well tolerated and produced an antitumor effect for advanced NSCLC. No significant financial relationships to disclose.

Randomized phase II study of maintenance vandetanib (ZD6474) in small cell lung cancer (SCLC) patients who have a complete or partial response to induction therapy: NCIC CTG BR.20

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7522-7522 ◽  
Author(s):  
A. M. Arnold ◽  
M. Smylie ◽  
K. Ding ◽  
Y. Ung ◽  
B. Findlay ◽  
...  
Keyword(s):  
Partial Response ◽  
Phase Ii ◽  
Randomized Study ◽  
Progression Free Survival ◽  
P Value ◽  
Cancer Society ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Dose Modifications ◽  
Ecog Ps

7522 Background: Vandetanib (V) is an inhibitor of vascular endothelial and epidermal growth factor receptors. This trial sought to determine whether maintenance V, given after standard chemotherapy (CT) and radiation (RT), prolonged progression-free survival (PFS) in responding patients with SCLC. Secondary endpoints: overall survival (OS) and toxicity. Methods: Phase II randomized, study of V 300 mg PO daily or placebo (P). Eligibility: complete (CR) or partial response (PR) to platinum-based CT, ECOG PS 0–2 and completion of RT (thoracic or prophylactic cranial). Statistics: 80% power to detect a 2.5 months improvement in median PFS (estimate for P of 4 months) using a 1-sided 10% level test (100 eligible patients; 77 events). Results: Between May 2003 and March 2006, 107 patients were accrued from 17 centres. Median follow up: 13.5 months. 46 had limited disease (LD); 61 extensive disease (ED). There were fewer PS 0 patients (11 vs. 20), and fewer had CR to initial CT (4 vs. 8) in the V arm. V patients were more likely to experience toxicity and require dose modification. The most frequent toxicities leading to dose modifications were gastrointestinal and rash. Clinically asymptomatic QTc prolongation was observed in 8 V patients. 83 of 107 patients developed progressive disease (43 on V; 40 on P). The median PFS for V was 2.7 months (80% C.I.: 1.1 –4.5) and 2.8 months for P (80% C.I.: 1.9 –5.6); estimated hazard ratio (HR) was 1.01 for V vs P (80% C.I.: 0.75 –1.36, 1-sided P-value = 0.51). Median OS for V was 10.6 months vs. 11.9 months for P; HR was 1.43 for V vs. P (80% C.I.: 1.00 –2.05, 1-sided P-value = 0.90). In a planned subgroup analysis, a significant interaction was noted (P-value = 0.01); with LD patients randomized to V having a longer OS (HR: 0.45, 1-sided P-value = 0.07), whereas ED patients randomized to V had a shorter OS compared to P (HR: 2.27, 1-sided P-value = 0.996). Conclusion: V failed to demonstrate efficacy as maintenance therapy for SCLC. Future targeted therapies should probably be explored concurrently with chemotherapy. This study was supported by the Canadian Cancer Society and AstraZeneca. [Table: see text]

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