Nivolumab (Nivo) and ipilimumab (Ipi) in combination with radiotherapy (RT) in high-risk patients (pts) with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6577-6577
Author(s):  
Jennifer Maria Johnson ◽  
Voichita Bar Ad ◽  
Emily Lorber ◽  
Dawn Poller ◽  
Gregor Manukian ◽  
...  
Keyword(s):  
High Risk ◽  
Checkpoint Inhibitors ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Lung Lesion ◽  
Primary Objective ◽  
Locoregional Control ◽  
Curative Therapy ◽  
Grade 3

6577 Background: Immune checkpoint inhibitors (ICI) are the standard of care in recurrent/metastatic SCCHN but their role in the curative therapy setting with RT is under study. We evaluated the novel approach of combining Nivo, a PD-1 inhibitor, and Ipi, a CTLA-4 inhibitor, in lieu of chemotherapy, with concurrent RT in pts with high-risk LA SCCHN. Methods: We enrolled newly diagnosed, chemotherapy eligible pts with AJCC 7th edition stage IVA-IVB SCCHN of the oral cavity, oropharynx (OP), hypopharynx, and larynx. HPV+ OP were T4, N2c or N3 OP. Nivo (3 mg/kg every 2 weeks IV x 17 doses) and Ipi (1 mg/kg every 6 weeks x 6 doses) were administered starting 2 weeks prior to the start of RT. RT was prescribed to a dose of 70 Gy delivered in 2 Gy/fraction/day using VMAT. The primary objective was safety of combination ICI with RT. Secondary objectives included 1-year progression-free survival (PFS), overall survival, and correlative studies. Results: 24 pts were enrolled; median age of 60 (range 48-77); 20 were male; 16 oropharynx (14 HPV+), 2 hypopharynx, and 6 larynx; AJCC 7th edition stage IVA (23), IVB (1). Grade 3 acute in-field adverse events (AEs) occurred in 17/24 (71%) of patients during concurrent ICI-RT (9 mucositis, 6 dysphagia, 5 dermatitis, 4 odynophagia, 1 dysphonia); there were no grade 4/5 AEs during ICI-RT. During ICI maintenance 5 pts developed in-field ulcerations at the primary site detected at an average of 3 months post RT; 1 of them died of bleeding due to erosion into the carotid artery with no evidence of active cancer; 4 additional pts developed in-field necrosis. 7 pts discontinued ICI treatment at > 3 months post-RT: 1 due to immune AE, 5 due to in-field ulcerations, 1 due to persistent mucositis without ulceration. 4 pts (17%) had grade 3 immune AEs: 1 elevation of lipase, 1 colitis, and 2 rash. There were no grade 4/5 immune AEs. The median follow-up is 16 months (range, 6.3-30.6). 21 of 24 pts (87.5%) are alive with no evidence of disease progression. 2 pts recurred at distant sites: 1 had a solitary lung lesion at 11 months and was treated with RT; 1 in mediastinal lymph nodes at 9 months and was treated with chemo-RT. Locoregional control remains at 100%. Conclusions: RT plus dual ICI combination was feasible and resulted in no locoregional relapses so far in 24 high-risk LA SCCHN pts. Longer follow-up is needed to fully assess PFS and locoregional control as well as post-treatment in-field ulceration/necrosis that may be attributed to the potent radiosensitizing effect of dual PD-1 and CTLA-4 blockade. Clinical trial information: NCT03162731 .

Phase II trial of pembrolizumab (MK-3475) in metastatic cutaneous squamous cell carcinoma: An updated analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21015-e21015 ◽  
Author(s):  
Melinda Lynne Yushak ◽  
David H. Lawson ◽  
Monica Goings ◽  
Marjorie Mckellar ◽  
Necia Maynard ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Stable Disease ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Primary Objective ◽  
Clinical Activity ◽  
Durable Response ◽  
Grade 3

e21015 Background: Cutaneous squamous cell carcinomas (cSCC) are generally curable with surgery and/or radiation. Unfortunately, some patients develop locally advanced or metastatic disease, with an estimated 3900 to 8700 patients dying of cSCC in 2012. Aggressive disease is often associated with immunosuppression, and no treatment has shown an improvement in overall survival (OS). Recently the FDA has approved cemiplimab-rwlc which targets PD-1. This abstract provides an updated analysis and additional followup for patients treated with pembrolizumab which also targets PD-1. Methods: Clinical activity of pembrolizumab in cSCC patients was evaluated in patients who were not curable by surgery and/or radiation. Patients were treated with pembrolizumab 200mg IV every 3 weeks for up to 2 years. Tumor response was measured every 12 weeks using RECIST version 1.1. Response rate (RR) of pembrolizumab in metastatic cSCC was the primary objective. 6-month progression-free survival (PFS) and 1 year OS were secondary objectives. Results: 11 subjects have been enrolled thus far with a median age of 70.3 years. Two were female and all were Caucasian. ORR per RECIST criteria was 64% with 18% (2) having a complete response, 36% (4) a partial response, 36% (4) progressive disease (PD), and 9% (1) stable disease. The patient with stable disease had a clinical response and was eventually able to undergo surgery that rendered him without any evidence of disease. 6 month PFS for evaluable patients was 72%. Of those patients with a response, 50% had a durable response of 18 months or greater at the time of data cut-off. No subject deaths have occurred on study. Three grade 3 related-adverse events were noted (hepatitis and pneumonitis). Conclusions: Pembrolizumab is active in advanced cSCC. Responses appear durable and comparable to what has been seen in previous studies with the FDA-approved agent, cemiplimab. No new safety concerns were noted. Additional follow up is needed in order to establish an OS benefit. Clinical trial information: NCT02964559.

Five-Year Outcomes of Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer-The Largest Experience in China

2021 ◽  
Author(s):  
Xianzhi Zhao ◽  
Yusheng Ye ◽  
Haiyan Yu ◽  
Lingong Jiang ◽  
Chao Cheng ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Cox Regression Analysis ◽  
Gu Toxicity ◽  
Biochemical Progression ◽  
Grade 3 ◽  
Very High

Abstract Objective To evaluate the efficacy and toxicity of SBRT for localized prostate cancer (PCa). Moreover, it is the largest-to-date pilot study to report 5-year outcomes of SBRT for localized PCa from China. Methods In this retrospective study, 133 PCa patients in our center were treated by SBRT with CyberKnife (Accuray) from October 2012 to July 2019. Follow-up was performed every 3 months for evaluations of efficacy and toxicity. Biochemical progression-free survival (bPFS) and toxicities were assessed using the Phoenix definition and the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 respectively. Factors predictive of bPFS were identified with COX regression analysis. Results 133 patients (10 low-, 21 favorable intermediate-, 31 unfavorable intermediate-, 45 high-, and 26 very high risk cases on the basis of the NCCN risk classification) with a median age of 76 years (range: 54–87 years) received SBRT. The median dose was 36.25Gy (range: 34-37.5Gy) in 5 fractions. Median follow-up time was 57.7 months (3.5–97.2 months). The overall 5-year bPFS rate was 83.6% for all patients. The 5-year bPFS rate of patients with low-, favorable intermediate-, unfavorable intermediate-, high-, and very high risk PCa was 87.5%, 95.2%, 90.5%, 86.3%, and 61.6% respectively. Urinary symptoms were all alleviated after SBRT. All the patients tolerated SBRT with only 1 (0.8%) and 1 (0.8%) patient reporting grade-3 acute and late genitourinary (GU) toxicity, respectively. There were no grade 4 toxicities. Gleason score (P < 0.001, HR = 7.483, 95%CI: 2.686–20.846) was the independent predictor of bPFS rate after multivariate analysis Conclusion SBRT is an efficient and safe treatment modality for localized PCa with high 5-year bPFS rates and acceptable toxicities.

Efficacy and tolerability of bevacizumab (BEV) plus capecitabine and cisplatin (XP) in Chinese patients (pts) with locally advanced or metastatic gastric/gastroesophageal junction cancer (AGC): Results from the AVATAR study.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 73-73 ◽  
Author(s):  
Lin Shen ◽  
Jin Li ◽  
Jian-Ming Xu ◽  
Hong-Ming Pan ◽  
Guanghai Dai ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Chinese Patients ◽  
Double Blind Study ◽  
Double Blind ◽  
Gastroesophageal Junction Cancer ◽  
The Difference ◽  
Grade 3

73 Background: In the AVAGAST study, chemotherapy (fluoropyrimidine and cisplatin) + BEV did not significantly improve overall survival (OS) vs. chemotherapy + placebo. Geographic differences in efficacy were observed, but only 12 Chinese pts were included. AVATAR, a study similar in design to AVAGAST, is a randomized double-blind study conducted exclusively in China in pts with AGC. Methods: Pts aged >18 years with gastric adenocarcinoma were randomized 1:1 to XP + BEV 7.5 mg/kg or placebo + XP. The primary objective was OS; secondary objectives included progression-free survival (PFS) and safety. Results: Baseline characteristics of the 202 pts were well balanced. The primary efficacy endpoint of improved OS in the BEV arm was not met (HR 1.11, 95% CI 0.79–1.56; p=0.5567; see table ). BEV + XP was well tolerated. Grade 3–5 adverse events (AEs) and serious AEs were 60% and 19% for BEV and 68% vs. 21% for placebo, respectively. Grade 3–5 AEs of special interest with BEV occurred in 8% of BEV pts and 15% of placebo pts; the difference was mainly due to grade 3–5 haemorrhage (BEV 4%, placebo 12%). Conclusions: Addition of BEV to XP in Chinese pts with AGC did not significantly improve outcomes in AVATAR. The results from AVATAR are consistent with the findings seen in the Asian sub-population of the previous AVAGAST study. [Table: see text]

Results of a phase III, randomized, double-blind, placebo-controlled trial of pegfilgrastim (PEG) in patients (pts) receiving first-line FOLFOX or FOLFIRI and bevacizumab (B) for colorectal cancer (CRC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3575-3575
Author(s):  
Tamas Pinter ◽  
Esteban Abella ◽  
Alvydas Cesas ◽  
Adina Croitoru ◽  
Jochen Decaestecker ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Double Blind ◽  
Free Survival ◽  
Clinically Significant ◽  
Grade 3

3575 Background: The literature reports that adding biologics to chemotherapy (ctx) may increase the incidence of clinically significant neutropenia. his trial was conducted to evaluate the efficacy of PEG in reducing the incidence of febrile neutropenia (FN) in pts with locally-advanced (LA) or metastatic (m)CRC receiving first-line treatment with either FOLFOX/B or FOLFIRI/B. Methods: Key eligibility: ≥ 18 years old; measurable, nonresectable CRC per RECIST 1.1. Pts were randomly assigned 1:1 to either placebo or 6 mg PEG ~24 h after ctx/B. The study treatment period included four Q2W cycles, but pts could continue their assigned regimen until progression. Pts were stratified by region (North America vs rest of world), stage (LA vs mCRC), and ctx (FOLFOX vs FOLFIRI). Estimated sample size (N = 800) was based on the expected incidence of grade 3/4 FN (primary endpoint) across the first 4 cycles of ctx/B, powered for PEG superiority over placebo. Other endpoints included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: 845 pts were randomized (Nov 2009 to Jan 2012) and received study treatment; 783 pts completed 4 cycles of ctx/B. Median age was 61 years; 512 (61%) pts were male; 819 (97%) had mCRC; 414 (49%) received FOLFOX, and 431 (51%) received FOLFIRI. Grade 3/4 FN (first 4 cycles) for placebo vs PEG was 5.7% vs 2.4%; OR 0.41; p = 0.014. A similar incidence of other ≥ grade 3 adverse events was seen in both arms (28% placebo; 27% PEG). See table for additional results. Conclusions: PEG significantly reduced the incidence of grade 3/4 FN in this pt population receiving standard ctx/B for CRC. Follow-up is ongoing. Clinical trial information: NCT00911170. [Table: see text]

RECIST and iRECIST criteria for the evaluation of nivolumab + ipilimumab combination in patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI/dMMR) metastatic colorectal cancer (mCRC): Results of the GERCOR NIPICOL phase II study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 101-101 ◽  
Author(s):  
Romain Cohen ◽  
Jaafar Bennouna ◽  
Julie Henriques ◽  
Christophe Tournigand ◽  
Christelle De La Fouchardiere ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Checkpoint Inhibitors ◽  
Low Frequency ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Free Survival ◽  
Previously Treated ◽  
Grade 3 ◽  
Clinical Trial Information

101 Background: Immune checkpoint inhibitors (ICKi) are highly effective for MSI/dMMR mCRC pts. RECIST1.1 criteria are reported to underestimate response to ICKi. The GERCOR NIPICOL phase II study aimed to evaluate disease control rate (DCR) using RECIST1.1 and iRECIST for MSI/dMMR mCRC pts treated with nivolumab (NIVO) and ipilimumab (IPI). Methods: MSI/dMMR mCRC pts previously treated with fluoropyrimidines (FP), oxaliplatin (OX) and irinotecan (IRI) ± targeted therapies received NIVO 3 mg/kg + IPI 1 mg/kg Q3W for 4 cycles then NIVO 3 mg/kg Q2W until progression or a maximum of 20 cycles. CT-scan tumor assessments were done every 6 weeks during 24 weeks and then every 12 weeks. Primary objective was DCR at 12 weeks (12wDCR) according to RECIST1.1 and iRECIST by central review. Response rates and progression-free survival (PFS) by central review were secondary objectives. A one-stage Fleming design was used with a targeted improvement of 12wDCR from 70% to 85%. Results: Of 57 pts included between Dec 2017 and Nov 2018, 43.9% had received ≥ 3 prior lines including FP (100%), OX (100%), IRI (95.5%), antiangiogenics (57.9%) and anti-EGFRs (45.6%). 17.5% of pts had BRAF mutation and 27.5% Lynch syndrome. Grade 3-4 treatment-related adverse events were reported in 49.1% of pts, mainly hepatitis (12.3%). 12wDCR was 86.0% and 87.7% using RECIST1.1 and iRECIST respectively, with only 1 pseudo-progression (1.8%) observed during the first 12 weeks, and one later. Kappa coefficient between RECIST and iRECIST 12wDCR was 0.92 (95%CI 0.77-1.0). Best observed responses with RECIST1.1/iRECIST were: 2/2 complete responses (3.5/3.5%), 19/19 partial responses (33.3/33.3%), 30/31 stable diseases (52.6/54.4%) and 3/2 disease progressions (5.3/3.5%), with 3 pts not evaluable (cancer-related deaths before first evaluation). Conclusions: Combination of NIVO and IPI in MSI/dMMR mCRC is associated with a low frequency of pseudo-progression and high DCR rate. PFS will be evaluated in Dec 2019, with all pts having completed the predefined 1-year of ICKi therapy. Clinical trial information: NCT033501260.

scholarly journals A Prospective Study to Evaluate the Effect of Paclitaxel on Cardiac Ejection Fraction

Breast Care ◽  
2017 ◽  
Vol 12 (4) ◽  
pp. 255-259 ◽  
Author(s):  
Mohammed Osman ◽  
Mohammad Elkady
Keyword(s):  
High Risk ◽  
Ejection Fraction ◽  
Prospective Study ◽  
Performance Status ◽  
Primary Objective ◽  
Cardiac Ejection Fraction ◽  
Grade 3 ◽  
A Prospective Study

Background: The primary objective of the study was to evaluate the long-term changes in ejection fraction (EF) associated with paclitaxel infusion. Methods: 50 patients were enrolled in this prospective study between 2011 and 2015. The study design included frequent follow-up visits to the clinic, EF evaluation at baseline, and regular EF assessment by echocardiography for 30 months after treatment. Results: The median baseline EF was 60% (95% confidence interval (CI) 50-80%). At 30 months, the median EF was 48% (95% CI 40-60%; p = 0.03). During the 30-month follow-up, 10 (20%) patients developed grade 1 and 2 cardiotoxicities; none developed grade 3 or 4 cardiotoxicities. Furthermore, paclitaxel cardiotoxicity increased among patients with high-risk features including associated diabetes mellitus, hypertension, prior radiotherapy to the chest wall, performance status of 2, and age > 60 years. Conclusion: Paclitaxel has cardiotoxic effects. Careful monitoring of cardiac function during and after paclitaxel infusion is required in patients with high-risk features.

scholarly journals Adding venetoclax to fludarabine/busulfan RIC transplant for high risk MDS and AML is feasible, safe, and active

2021 ◽  
Author(s):  
Jacqueline S Garcia ◽  
Haesook T Kim ◽  
H. Moses Murdock ◽  
Corey S Cutler ◽  
Jennifer Brock ◽  
...  
Keyword(s):  
High Risk ◽  
Myeloproliferative Neoplasms ◽  
Phase 1 ◽  
Chronic Gvhd ◽  
Progression Free Survival ◽  
Platelet Recovery ◽  
Free Survival ◽  
Transplant Patients ◽  
Grade 3

Adding the selective BCL-2 inhibitor venetoclax to reduced intensity conditioning (RIC) chemotherapy (fludarabine and busulfan, FluBu2) may enhance anti-leukemic cytotoxicity and thereby reduce the risk of post-transplant relapse. This phase 1 study investigated the recommended phase 2 (RP2D) of venetoclax, a BCL-2 selective inhibitor, when added to FluBu2 in adult patients with high risk acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and MDS/myeloproliferative neoplasms (MPN) undergoing transplant. Patients received dose-escalated venetoclax (200-400 mg daily starting day -8 for 6-7 doses) in combination with fludarabine 30 mg/m2/day for four doses and busulfan 0.8 mg/kg twice daily for eight doses on day -5 to -2 (FluBu2). Transplant related-toxicity was evaluated from the first venetoclax dose on day -8 to +28. Twenty-two patients were treated. At study entry, 5 MDS and MDS/MPN patients had 5-10% marrow blasts and 18/22 (82%) had a persistent detectable mutation. Grade 3 adverse events included mucositis, diarrhea and liver transaminitis (N=3 each). Neutrophil/platelet recovery and acute/chronic GVHD rates were similar to standard FluBu2. No DLTs were observed. The RP2D of venetoclax was 400 mg daily for 7 doses. With a median follow-up of 14.7 months (8.6-24.8 months), median overall survival was not reached, and progression free survival was 12.2 months (95% CI: 6.0 months, not estimable). In high risk AML, MDS, and MDS/MPN patients, adding venetoclax to FluBu2 was feasible and safe. To further address relapse risk, assessment of maintenance therapy after venetoclax plus FluBu2 transplant is on-going. This study was registered at clinicaltrials.gov as #NCT03613532.

scholarly journals Five-year outcomes of stereotactic body radiation therapy (SBRT) for prostate cancer: the largest experience in China

2021 ◽  
Author(s):  
Xianzhi Zhao ◽  
Yusheng Ye ◽  
Haiyan Yu ◽  
Lingong Jiang ◽  
Chao Cheng ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Patient Reporting ◽  
Cox Regression Analysis ◽  
Gu Toxicity ◽  
Grade 3 ◽  
Very High

Abstract Objective To evaluate the efficacy and safety of SBRT for localized prostate cancer (PCa) with CyberKnife in China. Moreover, it is the largest-to-date pilot study to report 5-year outcomes of SBRT for localized PCa from China. Methods In this retrospective study, 133 PCa patients in our center were treated by SBRT with CyberKnife (Accuray Inc., Sunnyvale, USA) from October 2012 to July 2019. Follow-up was performed every 3 months for efficacy and toxicity evaluation. Biochemical progression-free survival (bPFS) and toxicities were assessed using the Phoenix definition and the Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, respectively. Factors predictive of bPFS were identified with COX regression analysis. Results 133 patients (10 low-, 21 favorable intermediate-, 31 unfavorable intermediate-, 45 high-, and 26 very high risk cases on the basis of NCCN risk classification) with a median age of 76 years (range 54–87 years) received SBRT. The median dose was 36.25 Gy (range 34–37.5 Gy) in 5 fractions. Median follow-up time was 57.7 months (3.5–97.2 months). The overall 5-year bPFS rate was 83.6% for all patients. The 5-year bPFS rate of patients with low-, favorable intermediate-, unfavorable intermediate-, high-, and very high risk PCa was 87.5%, 95.2%, 90.5%, 86.3%, and 61.6%, respectively. Urinary symptoms were all alleviated after SBRT. All patients tolerated SBRT with 1 (0.8%) patient reporting grade-3 acute and 1 (0.8%) patient reporting grade-3 late genitourinary (GU) toxicity, respectively. There were no grade 4 toxicities. Gleason score (P < 0.001, HR = 7.483, 95%CI: 2.686–20.846) was the independent predictor of bPFS rate after multivariate analysis. Conclusion SBRT is an efficient and safe treatment modality for localized PCa with high 5-year bPFS rates and acceptable toxicities.

Phase II study of concurrent cetuximab (C225) plus definitive thoracic radiotherapy (XRT) followed by adjuvant docetaxel in poor prognosis patients with locally advanced non-small cell lung cancer (LA-NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7065-7065
Author(s):  
Thomas J. Dilling ◽  
Martine Extermann ◽  
Jongphil Kim ◽  
Lora Thompson ◽  
Binglin Yue ◽  
...  
Keyword(s):  
Recursive Partitioning ◽  
Locally Advanced ◽  
Failure To Thrive ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Therapy Compliance ◽  
Grade 3 ◽  
Early Radiation ◽  
Ecog Ps ◽  
Historical Controls

7065 Background: Recursive partitioning analysis has shown that ECOG PS ≥ 2, male gender, or age > 70 are prognostic of poor outcome in LA-NSCLC pts. Concurrent chemoradiotherapy improves survival, but toxicity is concerning in this frail pt cohort. We therefore opened this trial of concurrent definitive-dose XRT (70 Gy in 35 fractions) and C225 (250 mg/m2/dose), followed by adjuvant C225 and docetaxel (60 mg/m2 q3weeks x 3 cycles). Methods: Eligible patients had pathologically-proven LA-NSCLC (stage IIA – “dry” IIIB), not surgically resectable. They had ECOG PS 2 OR weight loss ≥5% in 3 months OR age >70. The primary objective was progression-free survival (PFS). Secondary objectives included overall survival (OS) and overall response rate (ORR). Results: From 5/2008 to 11/2010, 32 pts were evaluated for our single-institution, IRB-approved prospective clinical trial. 3 pts were screen-failures and 2 more withdrew consent prior to treatment, leaving 27 evaluable patients. 1 was removed due to poor therapy compliance and 2 were taken off trial due to grade 3 toxicity from the C225 loading dose, but were followed under intent-to-treat analysis. Median follow-up and OS was 10.5 months. Median PFS was 7.8 months. ORR = 59.3%. 8 early/sudden deaths were reported, so the trial closed early: radiation pneumonitis (RP) was the apparent cause in 1 and probably/possibly in 4 others, with insufficient information in 2 additional pts; 1 pt died of failure to thrive. Of the remaining pts, 3 developed grade 3+ RP and 2 had grade 2 RP. Conclusions: Pts enrolled on this trial had improved OS compared with poor-PS historical controls (10.5 vs 6.3 months) and comparable OS compared with good-PS historical controls (10.5 vs 11.9 months) treated with RT (Werner-Wasik M et al. Int J Radiat Oncol Biol Phys. 2000;48:1475-82). However, pulmonary toxicity is a concern. Analysis of RP events is ongoing. Updated results will be presented at the meeting.

Results of a phase III, randomized, double-blind, placebo-controlled trial of pegfilgrastim (PEG) in patients (pts) receiving first-line FOLFOX or FOLFIRI and bevacizumab (B) for colorectal cancer (CRC).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. LBA445-LBA445 ◽  
Author(s):  
Tamas Pinter ◽  
Steve Abella ◽  
Alvydas Cesas ◽  
Adina Croitoru ◽  
Jochen Decaestecker ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
Double Blind ◽  
Free Survival ◽  
Clinically Significant ◽  
Grade 3

LBA445 Background: The literature reports that adding biologics to chemotherapy (ctx) may increase the incidence of clinically significant neutropenia. This trial was conducted to evaluate the efficacy of PEG in reducing the incidence of febrile neutropenia (FN) in pts with locally advanced (LA) or metastatic (m)CRC receiving first-line treatment with either FOLFOX/B or FOLFIRI/B. Methods: Key eligibility: ≥ 18 years old; measurable, nonresectable CRC per RECIST 1.1. Pts were randomly assigned 1:1 to either placebo or 6 mg PEG ~24 h after ctx/B. The study treatment period included four Q2W cycles, but pts could continue their assigned regimen until progression. Pts were stratified by region (North America vs rest of world), stage (LA vs mCRC), and ctx (FOLFOX vs FOLFIRI). Estimated sample size (N = 800) was based on the expected incidence of grade 3/4 FN (primary endpoint) across the first 4 cycles of ctx/B, powered for PEG superiority over placebo. Other endpoints included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: 845 pts were randomized (Nov 2009 to Jan 2012) and received study treatment; 783 pts completed 4 cycles of ctx/B. Median age was 61 years; 512 (61%) pts were male; 819 (97%) had mCRC; 414 (49%) received FOLFOX, and 431 (51%) received FOLFIRI. Grade 3/4 FN (first 4 cycles) for placebo vs PEG was 5.7% vs 2.4%; OR 0.41; p = 0.014. A similar incidence of other ≥ grade 3 adverse events was seen in both arms (28% placebo; 27% PEG). See Table for additional results. Conclusions: PEG significantly reduced the incidence of grade 3/4 FN in this pt population receiving standard ctx/B for CRC. Follow-up is ongoing. Clinical trial information: NCT00911170. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document