A phase II trial of gefitinib in recurrent and metastatic nasopharyngeal carcinoma pretreated with platinum-based chemotherapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6042-6042
Author(s):  
D. T. Chua ◽  
J. Sham ◽  
G. Au
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Growth Factor Receptor ◽  
Distant Metastases ◽  
Symptomatic Improvement ◽  
Eligibility Criteria ◽  
Minor Response ◽  
Egfr Expression ◽  
Platinum Based Chemotherapy ◽  
Disease Stabilization ◽  
Ecog Ps

6042 Background: Epidermal growth factor receptor (EGFR) is commonly expressed in nasopharyngeal carcinoma (NPC) and strong EGFR expression appears to correlate with poor survival. Gefitinib, a small-molecule inhibitor of the EGFR tyrosine kinase, has been shown to inhibit the growth of NPC cell lines. Methods: Nineteen patients with recurrent or metastatic NPC were recruited into the study. Eligibility criteria included: radiographic progression of disease, ECOG PS < 2, 1 or more prior platinum-based chemotherapy regimens, normal organ function. Fifteen patients were treated for first relapse, 3 for second relapse, and 1 for third relapse. Local disease was present in 8, nodal disease in 3, and distant metastases in 14. All patients had previously received platinum-based chemotherapy as adjuvant and/or palliative treatments, and 89.5% had 2 or more regimens. Patients received gefitinib 250 mg po daily. Median treatment duration was 10 weeks and median follow-up time was 9 months. Results: Minor response was observed in 2 patients treated for advanced local recurrence. There were no complete or partial responders. Seven patients had stable disease and 12 had progressive disease. Median time to progression was 4 months and median survival was 14 months. Progression-free rate at 6 months was 22% and 1-year survival rate was 70%. Treatment was generally well tolerated and only grade 1–2 adverse events were observed, with acneiform rash (68.5%), fatigue (36.9%), diarrhea (31.6%), and anorexia (31.6%) most common. In 15 patients with symptoms related to NPC, 5 reported improvement, 5 reported no changes, and 5 reported worsening during gefitinib treatment. Conclusions: Gefitinib has little activity in terms of response rate in recurrent and metastatic NPC, although disease stabilization and symptomatic improvement were observed in some patients. Evaluation of markers of EGFR pathway on tumor tissue is currently being performed. No significant financial relationships to disclose.

A phase II trial of gefitinib in patients (pts) with progressive metastatic neuroendocrine tumors (NET): A Phase II Consortium (P2C) study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4043-4043 ◽  
Author(s):  
T. J. Hobday ◽  
K. Holen ◽  
R. Donehower ◽  
J. Camoriano ◽  
G. Kim ◽  
...  
Keyword(s):  
Phase Ii ◽  
Treatment Options ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Target Lesion ◽  
Eligibility Criteria ◽  
Minor Response ◽  
Islet Cell Carcinoma ◽  
Disease Stabilization ◽  
Ecog Ps

4043 Background: Systemic treatment options for progressive metastatic NET, including islet cell carcinoma (ICC) and carcinoid tumor (CT), are limited. These tumors frequently express the epidermal growth factor receptor (EGFR). Gefitinib, a small-molecule inhibitor of the EGFR tyrosine kinase, has been shown to inhibit the growth of NET cell lines. Methods: Eligibility criteria included: radiographic progression by RECIST criteria, ECOG PS ≤ 2, ≤ 1 prior chemotherapy, and good organ function. Prior interferon and prior or concurrent octreotide (if disease progression documented on stable dose) were allowed. Pts received gefitinib 250 mg po daily. We evaluated 6 month (mos) progression-free survival (PFS) in two cohorts (ie, CT and ICC) using separate 2-stage phase II designs. 6 mos PFS rates of 30% (CT) and 10% (ICC) were considered promising. Results: 96 pts were enrolled: (57 CT, 39 ICC). For pts evaluable for the primary endpoint, 23 of 38 (61%) CT pts and 9 of 29 (31%) pts with ICC were progression-free at 6 mos. 1 PR and one minor response (MR = 20–29% decrease in sum of target lesion diameters) were observed in 40 CT pts; 2 PR and 1 MR in 31 ICC pts. In addition, 32% (12/38) of CT and 14% (4/29) of ICC pts had stable disease on study for a duration that exceeded by at least 4 months the time to progression documented prior to study entry. Grade 3–4 toxicity was infrequent with fatigue (6%), diarrhea (5%) and rash (3%) most common. Evaluation of markers of the EGFR pathway on tumor tissue will be presented. Conclusions: Gefitinib is well-tolerated and results in prolonged disease stabilization in pts with prior documented objective progression of CT and ICC, with rare objective responses. Supported by NOI CM17104. No significant financial relationships to disclose.

Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4519-4519 ◽  
Author(s):  
B. A. Burtness ◽  
M. Powell ◽  
J. Berlin ◽  
D. Liles ◽  
A. Chapman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Advanced Pancreatic Cancer ◽  
Growth Factor Receptor ◽  
Distant Metastases ◽  
Median Number ◽  
Number Of Cycles ◽  
Ecog Ps

4519 Background: Gemcitabine (G) is standard for metastatic pancreatic cancer (PC), with median survivals of 6 months (m). Second cytotoxic or biologic agents do not substantially advance survival. EGFR is expressed on PC and a phase II trial of G plus cetuximab (C) resulted in favorable 1 year survival. A phase II trial of irinotecan/docetaxel (I/D) chemotherapy reported a median survival for metastatic patients (pts) of 9 m. We conducted this randomized phase II trial to confirm the activity of this non-G regimen, and determine whether combining it with C was feasible and active. The primary endpoint was response. Methods: Pts required histologic confirmation of adenocarcinoma of the pancreas, evidence of distant metastases, ECOG PS 0–1, normal bilirubin, written informed consent, and were randomly assigned to Arm A (N=47) or B (N=45). Imaging with CT or MR within 4 weeks (wk) was used for tumor measurement. Dexamethasone was given 12 hours (h), 1 h before and 12 h after chemotherapy. Pts on Arm A received D 35 mg/m2 over 1 h and I 35 mg/m2 over 30 minutes weekly x 4 in a 6 wk cycle. Pts on Arm B received the same therapy, but C (loading dose 400 mg/m2 wk 1, 250 mg/m2 weekly thereafter) was given before D. Pts not receiving therapeutic anticoagulation received enoxaparin 40 mg per day. Pts were restaged (RECIST) after 2 cycles. Results: Median age Arm A: 59.9, Arm B: 60.2 years. Arm A 55% male, 32% PS 0, 97% EGFR immuno+. Arm B 84% male, 42% PS 0, 97% EGFR +. Median number of cycles for each arm 2 (1 -10). >4 cycles were delivered to 10.5% of pts Arm A, 20.9% Arm B. Grade ¾ neutropenia 26% Arm A, 33% Arm B. Grade 3 nausea 28% Arm A, 18% Arm B; Grade ¾ diarrhea 33% Arm A, 44.4% Arm B. 1 treatment-related death per arm. Median overall survival (OS), with 70.2% of pts known to have died, 6.5m [(95% CI (4.8, 8.6)] in Arm A. With 86.7% of pts known to have died in Arm B, OS 7.4 m [95% CI (4.4, 10.7)]. Response/progression data will be available at time of presentation. Conclusions: Weekly I/D ± C is associated with high rates of grade ¾ neutropenia/diarrhea. Median survival is 6.5m for I/D and 7.4m for I/D/C. Non-G containing therapy is active in metastatic PC. [Table: see text]

Phase II trial of high dose imatinib in recurrent glioblastoma multiforme (GBM) with platelet derived growth factor receptor (PDGFR) expression

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2056-2056 ◽  
Author(s):  
F. S. Viola ◽  
A. Katz ◽  
A. Arantes ◽  
A. Gaiger ◽  
C. Vasconcellos ◽  
...  
Keyword(s):  
Poor Prognosis ◽  
Significant Proportion ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Initial Therapy ◽  
Recurrent Glioblastoma ◽  
High Dose ◽  
Recurrent Glioblastoma Multiforme ◽  
Disease Stabilization ◽  
Ecog Ps

2056 Background: GBM are the most common primary brain tumors in adults. Despite available treatment they carry a poor prognosis with recurrences in most patients (pts) after initial therapy. PDGF signaling has been postulated to play a role in GBM transformation. We have demonstrated that PDGFRβ is expressed in tumor cells in 50% and in peritumoral endothelial cells in 65% of GBM (Barrios et al, abstract 11518, Proc ASCO 2006). Imatinib, an inhibitor of PDGFRa/β kinase activity could have therapeutic activity in these cases. Methods: We evaluated Imatinib in pts with recurrent GBM (previous radiation and chemotherapy) selected by PDGFR expression. Analysis of PDGFRa/β was performed by standard IHC. Positivity was considered in case of any qualitative expression. Pts were treated with 800 mg/day of Imatinib until tumor progression. All were on steroids and taking enzyme inducing antiepileptic drugs. Response was determined by MRI with spectroscopy and perfusion every 8 weeks according to RECIST criteria. Results: Twenty pts were enrolled (18 GBM, 2 AA). Median age: 51 (21–74), 7 were females. ECOG-PS at inclusion: 0 (3), 1 (10), 2 (7). All pts had expression of PDGFRa and 55% expressed PDGFRβ. Response data are available for all 20 pts. Main adverse events (all grade 1–2) were: edema (55%), nausea (50%), diarrhea and fatigue (35% each). We did not observe any PR but 13 pts (65%) showed disease stabilization. Median progression-free survival was 7.8 months with 60.8% of pts alive at 6 months; 6 months PFS was 52.2%. Conclusions: Imatinib was well tolerated in this group of poor prognosis highly pre-treated GBM pts demonstrating disease stabilization in a significant proportion of cases. These results, in a limited sample, compare favorably with historical data in similar populations. Selection of pts according to the specific molecular expression of their tumor may lead to better therapeutic results. No significant financial relationships to disclose.

Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: A phase II study of the Belgian Group of Digestive Oncology.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 245-245 ◽  
Author(s):  
I. Borbath ◽  
A. Ceratti ◽  
C. Verslype ◽  
A. Demols ◽  
T. Delaunoit ◽  
...  
Keyword(s):  
Skin Rash ◽  
Phase Ii ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Skin Toxicity ◽  
Standard Of Care ◽  
Egfr Expression ◽  
Prior Systemic Therapy ◽  
Ecog Ps

245 Background: Cholangiocarcinomas (CCK) are uncommon tumors with an increasing incidence and a poor prognosis. Epidermal growth factor receptor (EGFR) expression and activation in CCK have been demonstrated. Methods: We conducted a multicenter phase II trial combining cetuximab (Ctx), an anti-EGFR chimerized IgG1 monoclonal antibody, to gemcitabine (Gem). Patients with either locally advanced (LA) or metastatic (M) CCK (excluding gallbladder) were included; no prior systemic therapy was allowed. Ctx was administrated at the initial dose of 400 mg/m2 and further injections at 250 mg/m2 every 7 days, and Gem was administrated at 1000 mg/m2 on days 1, 8, and 15 every 4 weeks. The primary endpoint was the progression-free survival (PFS) rate at 6 months. A Simon 2-stage design was used. We hypothesized that Gem/Ctx would improve 6 month-PFS rate from 20% to 40%. We needed 3 patients with PFS ≥ 6 months from the first 13 to further include a total of 43 patients. Results: Forty-four patients with advanced CCK (41% LA/59%M) were enrolled from 09/2008 to 01/2010. Median age was 61.5 years (range 40-86) and baseline ECOG PS was 0 for 68% and 1 for 32% of the patients. Forty-three percent of the patients had prior surgery. Forty-six percent of the patients were free from progression at 6 months. Median PFS was 5.8 months (95% CI, 4.4-7.4 m) and median overall survival was 11.6 months (95% CI, 8.7-14.6 m). Nine patients (20.9%) had partial response with a median duration of 5 months (range 2-10 m). Disease control rate (PR + SD > 8 weeks) was 81.4%. The most common grades 3/4 related-toxicities were haematological abnormalities (47.7%), skin rash (13.6%) and fatigue (11.3%). Due to toxicity, 6 patients discontinued study treatment; 14 and 3 patients had a Gem and Ctx dose reduction respectively. Among the nine responders, 8 experienced a skin rash of at least grade 2, suggesting a relationship between skin toxicity and efficacy. Conclusions: Our study met its endpoint, i.e., a PFS rate of 46% at 6 months, suggesting that Gem-Ctx combination had promising activity with a manageable toxicity profile in advanced CCK. Adding Ctx to the new standard of care Gem-cisplatin deserves further investigations in CCK. [Table: see text]

MS201944-0170: A phase IIa study to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in patients with advanced squamous NSCLC.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS9123-TPS9123
Author(s):  
Fortunato Ciardiello ◽  
Manuel Cobo Dols ◽  
Oscar Juan Vidal ◽  
Luis G. Paz-Ares ◽  
Javier de Castro Carpeño ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Stage Iv ◽  
Clinical Activity ◽  
Alk Rearrangement ◽  
Eligibility Criteria ◽  
Prior Therapy ◽  
Platinum Based Chemotherapy ◽  
Treatment Naïve ◽  
Ecog Ps ◽  
Gemcitabine And Cisplatin

TPS9123 Background: Preclinical studies have demonstrated that cetuximab plus chemotherapy results in immunogenic cell death and an increase in CD8+ T cells in the tumor microenvironment. Avelumab (an anti–PD-L1 antibody) has previously shown antitumor activity in NSCLC. We hypothesize that the combination of cetuximab with platinum-based chemotherapy and avelumab may have synergistic antitumor activity. Methods: This phase IIa, single-arm, multicenter study is investigating the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in patients with advanced squamous NSCLC who are treatment naive in the advanced setting (NCT03717155). Eligibility criteria include histologically confirmed stage IV, metastatic or recurrent NSCLC with squamous histology, with no prior systemic therapy for metastatic NSCLC, no prior therapy with any antibody/drug targeting T-cell coregulatory proteins, and ECOG PS of 0 to 1. Patients with a tumor harboring an activating EGFR mutation or ALK rearrangement are excluded. Patients will receive doublet chemotherapy (cisplatin 75 mg/m2 on day 1, gemcitabine 1250 mg/m2 on days 1 and 8), cetuximab on days 1 (250 mg/m2) and 8 (500 mg/m2), and avelumab 800 mg on days 1 and 8 for a total of four 3-week cycles. Thereafter, avelumab (800 mg) and cetuximab (500 mg/m2) will be administered as maintenance treatment Q2W until disease progression, unacceptable toxicity, or withdrawal. Enrollment in a safety run-in, which will evaluate the safety and tolerability of avelumab in combination with cetuximab plus gemcitabine and cisplatin, is planned for the first 6 patients. Enrollment began on October 30, 2018. Study enrollment will continue until approximately 40 evaluable patients have been recruited. The primary endpoint is confirmed best overall response per RECIST 1.1 by investigator assessment. Secondary endpoints include safety (NCI CTCAE v5.0) and tolerability of the combination, duration of response, survival, and tumor biomarkers. The study is ongoing at sites in Hungary and Spain. Clinical trial information: NCT03717155.

A phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 3582-3582 ◽  
Author(s):  
D. Camidge ◽  
R. S. Herbst ◽  
M. Gordon ◽  
S. Eckhardt ◽  
R. Kurzroc ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colorectal Cancer Patient ◽  
Human Study ◽  
Symptomatic Improvement ◽  
Extrinsic Pathway ◽  
Minor Response ◽  
Igg1 Monoclonal Antibody ◽  
Grade 3 ◽  
A Minor ◽  
Ecog Ps

3582 Background: Apomab, a fully human affinity-matured IgG1 monoclonal antibody, is a DR5 pro-apoptotic receptor agonist that triggers the extrinsic pathway of apoptosis. DR5 is expressed both on malignant and normal cells; however, pre-clinical data indicate that DR5 activation stimulates apoptosis predominantly in malignant cells. This first-in-human study assessed the safety, pharmacokinetics (PK) and any early evidence of anti-cancer efficacy of Apomab. Methods: Patients with advanced treatment-refractory solid tumors received Apomab IV on Day1 (cycle 1 = 28 days, cycles 2–8 = 14 days) at 1, 4, 10, 15, or 20 mg/kg (stage 1); with cohort expansion at 10 mg/kg or the MTD (if lower) every 14 days (stage 2). Tumor assessments were made after 2, 4 and 8 cycles. Therapy continued past 2 cycles as permitted by on-going evidence of benefit, until disease progression or unacceptable toxicity occurred. Results: 26 patients ECOG PS ≤1 have been enrolled and treated through 20 mg/kg. The 20 (8M, 12F) with confirmed data (up to 15mg/kg) received a median of 2 cycles (range 1–8). All dose levels have been tolerable (<33% dose limiting (Grade 3 drug-related) toxicities in the first 2 doses + 24 hours). 2 disparate DLTs occurred among 11 patients treated at 10 mg/kg. 1 patient (ovarian cancer) had asymptomatic transaminitis (ALT and AST) at C1D5, reaching Grade 3 by D29, received no further Apomab with resolution by D53. 1 patient (colorectal cancer) had a pulmonary embolism C1D4. Six patients completed at least 4 cycles of Apomab, 4 completed 8 cycles. No objective responses have been seen but at 10 mg/kg 1 patient (appendiceal cancer) remains on study (stable disease) past 8 cycles and 1 patient (colorectal cancer) had 28% shrinkage of target lesions and symptomatic improvement after 4 cycles. PK of Apomab is dose-proportional at 1 and 4 mg/kg with a typical IgG1 half-life of ∼15–20 days. AUC/Css,min concentrations at >4 mg/kg are greater than those displaying activity in preclinical models. No HAHA responses have been seen to date. Conclusions: Apomab is well tolerated with a minor response seen in a colorectal cancer patient. Enrollment is continuing at 10mg/kg. Further safety and efficacy data will be presented. No significant financial relationships to disclose.

A prospective phase II trial of gemcitabine plus axitinib in patients with sarcomatoid type renal carcinoma.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 616-616
Author(s):  
Inkeun Park ◽  
Hyo Jin Lee ◽  
Woo Kyun Bae ◽  
Shinkyo Yoon ◽  
Jae-Lyun Lee
Keyword(s):  
Cell Carcinoma ◽  
Treatment Options ◽  
Objective Response ◽  
Sarcomatoid Carcinoma ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Uncontrolled Hypertension ◽  
Eligibility Criteria ◽  
Median Percentage ◽  
Ecog Ps

616 Background: Sarcomatoid renal cell carcinoma (SRCC) is a rare but very aggressive type of RCC. The treatment option for SRCC is very limited, and there have been anecdotal reports of very good responders to gemcitabine or vascular endothelial growth factor receptor tyrosine kinaase inhibitors (VEGFR TKI). We conducted multicenter phase 2 trial of gemcitabine plus axitinib (GX) in patients (pts) with recurrent or metastatic SRCC to evaluate its efficacy and safety. Methods: Eligibility criteria included histologically confirmed metastatic or recurrent RCC with sarcomatoid component of 25% or more on resected kidney or exclusive sarcomatoid carcinoma on needle biopsy, ECOG PS 0-2, measurable lesion by RECIST v1.1, and adequate cardiac, hepatic, renal and bone marrow function. Pts with uncontrolled hypertension, prior exposure to gemcitabine or VEGFR TKI were exclude. Pts received gemcitabine 1,000 mg/m2 intravenously on days 1 and 8 by 3-week cycle and axitinib 5 mg twice daily. The primary endpoint was objective response rate (ORR) according to RECIST v1.1, and secondary end points were progression-free survival (PFS), overall survival (OS), and toxicity. Results: Twenty-five pts were enrolled between Oct 2014 and Aug 2018. Median age was 61 (range 33-80), and 84% was male. ECOG PS were 1 (92%) and 2 (8%), and 52% had prior nephrectomy. Clear cell carcinoma was the most common histology of carcinoma component, and median percentage of sarcomatoid component was 90% (25-100%). Pts belonged to intermediate (28%) and poor (72%) risk group according to IMDC risk stratification. Median 6 cycles of GX were administered, and 56%, 28%, and 12% of pts achieved PR, SD, and PD, respectively, with an ORR of 56% and median duration of response of 2.5 months. With a median follow-up duration of 21.4 mo, median PFS was 4.9 mo (95% CI, 3.5-13.3), and median OS was 8.4 months (95% CI 3.5-13.3 months). Most adverse events were manageable, and no unexpected toxicities were found. One pt died of grade 5 pneumonia. Conclusions: GX showed promising efficacy in pts with SRCC. GX might be considered as one of treatment options for pts with SRCC, although efficacy of GX should be confirmed in larger trial.

scholarly journals EPIDERMAL GROWTH FACTOR RECEPTOR EXPRESSION IN NON-KERATINIZED NASOPHARYNGEAL CARCINOMA SUBTYPE AT PADANG

2019 ◽  
Vol 1 (02) ◽  
pp. 73-74
Author(s):  
Histawara Subroto ◽  
Sukri Rahman ◽  
Bestari J Budiman ◽  
Aswiyanti Asri ◽  
Hafni Bachtiar
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Nasopharyngeal Carcinoma ◽  
Epidermal Growth Factor ◽  
Clinical Stage ◽  
Growth Factor Receptor ◽  
Receptor Expression ◽  
Cross Sectional ◽  
Egfr Expression ◽  
Epidermal Growth

Introduction: Patients with nasopharyngeal carcinoma have a poor prognosis, there are several factors that cause it to happen, one of the existing therapeutic response has been inadequate. Expression of Epidermal Growth Factor Receptor (EGFR) has been used as a biological marker targeted therapy in nasopharyngeal carcinoma. Histopathologic subtype tumors also determine the prognosis of patients with nasopharyngeal carcinoma. Objective: The aim of the study to determine between the expression of epidermal growth factor receptor between non-keratinized differentiated and undifferentiated subtypes in nasopharyngeal carcinoma and correlation with their clinical stage. Study design, Cross-sectional comparative study. Place and duration study, Department of Otorhinolaryngology, Department of Pathology Anatomy in Dr. M. Djamil Hospital, Padang and Department of Pathology Anatomy in Gajah Mada University, between May 2015 until October 2015 Material and methods: We included 36 samples paraffin blocks of nasopharyngeal carcinoma biopsy, respectively 18 paraffin blocks are non-keratinized differentiated and 18 non-keratinized undifferentiated nasopharyngeal carcinoma subtypes. Each sample examined EGFR expression by immunohistochemical staining methods. Results: There were positive EGFR expression results in all sample as 69.4%. Expression of EGFR positive non-keratinized differentiated subtypes in nasopharyngeal carcinoma as 77.8% and undifferentiated subtype as 61.6%. There are no significant differences of EGFR expression between non keratinized differentiated and undifferentiated subtypes nasopharyngeal carcinoma (P>0.05). There are no significant differences of EGFR expression between new and advanced stage nasopharyngeal carcinoma (P>0.05). Conclusion: There were no significant differences of EGFR expression between non-keratinized differentiated and non-keratinized undifferentiated subtypes in nasopharyngeal carcinoma. Analysis of the study also showed no significant differences of EGFR expression based on the clinical stage nasopharyngeal carcinoma.

A phase II trial of adding cetuximab to cisplatin and gemcitabine as first-line therapy in advanced non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19043-e19043
Author(s):  
F. Barata ◽  
B. Parente ◽  
E. Teixeira ◽  
A. Costa ◽  
A. Fernandes ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase Ii ◽  
Line Treatment ◽  
Eligibility Criteria ◽  
Intention To Treat ◽  
First Line Therapy ◽  
Kaplan Meier ◽  
Platinum Based Chemotherapy ◽  
Portuguese Study ◽  
Ecog Ps

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.

scholarly journals Nimotuzumab plus platinum-based chemotherapy versus platinum-based chemotherapy alone in patients with recurrent or metastatic nasopharyngeal carcinoma

2020 ◽  
Vol 12 ◽  
pp. 175883592095373
Author(s):  
Yunshu Zhu ◽  
Sheng Yang ◽  
Shengyu Zhou ◽  
Jianliang Yang ◽  
Yan Qin ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Multivariable Analysis ◽  
Growth Factor Receptor ◽  
Treatment Compliance ◽  
Progression Free Survival ◽  
Medical Sciences ◽  
Platinum Based Chemotherapy ◽  
Significant Difference ◽  
Metastatic Nasopharyngeal Carcinoma ◽  
Epidermal Growth

Background: Palliative chemotherapy has been the mainstay treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC). However, little is known about the efficacy and toxicity of nimotuzumab (NTZ) – a monoclonal antibody drug targeting epidermal growth factor receptor – plus chemotherapy (CT) versus CT alone for these patients. Methods: The database at Cancer Hospital of Chinese Academy of Medical Sciences was queried for patients diagnosed with NPC who received CT with or without NTZ between 2004 and 2018. Treatment compliance, survival outcomes, and adverse effects were compared among these groups. Results: Records of 70 patients with R/M-NPC were reviewed: 21 (30%) received NTZ plus CT (NTZ+CT) and 49 (70%) received CT. CT regimens included gemcitabine plus platinum, taxane plus platinum (TP), and fluorouracil plus platinum. Comparing the CT group with NTZ+CT group, the median follow up was 62 months (range = 3–133) versus 59 months (range = 9–117); median progression free survival was 7.5 [95% confidence interval (CI) 6.552–8.381] months versus 8.5 (95% CI 6.091–10.976) months, p = 0.424; median overall survival (OS) was 25.6 (95% CI 18.888–32.379) months versus 48.6 (95% CI 35.619–61.581) months, p = 0.017, respectively. Multivariable analysis established treatment group (CT versus NTZ+CT) as an independent prognostic factor for OS (hazard ratio, 0.5; 95% CI 0.255–0.979; p = 0.043). No significant difference with regard to toxicities was observed between the two groups. Among them, a subgroup analysis was performed in 53 (75.7%) patients who received TP with or without NTZ, which showed similar results. Conclusion: Our findings suggested that NTZ+CT provides a novel treatment option and prolongs survival significantly for R/M-NPC.

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