High Quality - Low Cost Anti-Cancer Drugs
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Overall survival (OS) results from OPTIMAL (CTONG0802), a phase III trial of erlotinib (E) versus carboplatin plus gemcitabine (GC) as first-line treatment for Chinese patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).
In vitro assays of cytochrome P450 metabolism showed that erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2, and the extrahepatic isoform CYP1A1.
INTRODUCTION: Erlotinib drug is commonly known as HCl salt. It is also called as OSI-420 EGFR inhibitor . It is a small molecule of tyrosine kinase inhibitor that works against the receptor for epidermal growth factor. This epidermal growth factor results usually very high levels of expression and mostly gets mutated in case of various types of tumors, hence a valuable and attractive target for anti-tumor therapy [1]. One can order OSI-420 to any of the supplier OSI-420 . So one can purchase OSI-420 by paying Erlotinib price to its supplier that is around $65 for 1000 mg vial. Erlotinib structure describes that it has 2 rings of quinazoline. OSI-420 has found to be inhibiting the autophosphorylation of epidermal growth factor to render downstreaming of already stopped signaling cascade by binding to ATP binding site of EGFR in the reversible manner leading to a permanat change in its conformation or structure. Erlotinib solubility is 18 mg/ml in DMSO while it is very poorly soluble in water and ethanol. To inhibit EGFR tyrosine kinase enzyme in human, Erlotinib IC50 was found to be almost 20 nM [2]. OSI-420 EGFR inhibitor must be kept far away from different oxidizing agents so that it will remain stable and safe.
ea-me.de/index.php?do=/blog/63289/posted...rlotinib-rash-grade/
Erlotinib Carboxylic Acid
The metabolism of Erlotinib can be decreased when combined with Venlafaxine.
In conclusion, erlotinib has moderate efficacy for pretreated SCC in Japanese patients. Greater benefit can be expected in patients who develop a higher grade of skin rash. The incidence of ILD can be minimized by careful examinations to exclude pre-existing ILD. As our study is retrospective and the sample size is small, further prospective study is warranted to confirm the efficacy and safety of erlotinib (especially the incidence and severity of ILD) in Japanese SCC patients.
Erlotinib and pemetrexed have been approved for the second-line treatment of non-small cell lung cancer. Recent reports indicated that erlotinib and pemetrexed exerted synergistic effects against lung adenocarcinoma. The available treatment options for lung cancer with brain metastases (BM) are currently limited. In the present study, we investigated the efficacy of the combined administration of erlotinib and pemetrexed in 9 patients with epidermal growth factor receptor (EGFR) wild-type lung adenocarcinoma with BM. Pemetrexed (500 mg/m2) and cisplatin (20 mg/m2) were administered on day 1 and days 1-3, respectively. Erlotinib (150 mg) was administered daily on days 4-20. The 9 patients harbored EGFR wild-type mutation in the primary tumor tissues. With regard to the BM, no patients achieved complete remission, 7 patients exhibited a partial response (PR), 1 had stable disease (SD) and 1 had progressive disease (PD). As regards the extracranial tumors, 3 patients exhibited a PR, 2 had SD, 3 had PD and 1 was not applicable. The performance status and the symptoms improved in 3 patients following treatment. The median progression-free survival for intracranial and extracranial disease control was 179 and 146.5 days, respectively. The median overall survival was 197.4 days. Therefore, erlotinib combined with pemetrexed/cisplatin, was found to be effective in the treatment of patients with EGFR wild-type lung adenocarcinoma.
forum.drujba-konserv.com/viewtopic.php?p=12534#12534
Ik gebruik nu 3 jaar tarceva en het werkt bij mij geweldig, 4jaar geleden ben ik begonnen met chemo kuren maar het resultaat was 0, als laatste kon ik nog taceva proberen en dit werkte voor mij geweldig. Ik heb wel alle bijwerkingen gehad die op het lijstje staan en meer. Nog steeds heb ik veel last van mijn teennagels. Maar dat zijn kleinigheden zeker bij de mededeling va [lees meer. ] n de longarts 4 jaar geleden: u hebt nog 4 tot 6 maanden. Ik gebruik nu 3 jaar tarceva en het werkt bij mij geweldig, 4jaar geleden ben ik begonnen met chemo kuren maar het resultaat was 0, als laatste kon ik nog taceva proberen en dit werkte voor mij geweldig. Ik heb wel alle bijwerkingen gehad die op het lijstje staan en meer. Nog steeds heb ik veel last van mijn teennagels. Maar dat zijn kleinigheden zeker bij de mededeling van de longarts 4 jaar geleden: u hebt nog 4 tot 6 maanden.
The National Institute for Health and Clinical Excellence has published final draft guidance supporting Tarceva (erlotinib) as an option to treat patients with locally advanced or metastatic EFGR mutation-positive NSCLC.
Risk Summary Based on its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. When given during organogenesis, erlotinib administration resulted in embryo-fetal lethality and abortion in rabbits at doses approximately 3 times the recommended human daily dose of 150 mg. If Tarceva is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.11 )] .
erlotinib (150 mg PO QD) (Arm Image may be NSFW.
Clik here to view.
greekschool.ru/index.php/forum/razdel-pr...5-erlotinib-approval
Should I avoid certain foods while taking erlotinib?
在洁净干燥的250mL四口烧瓶中，投入埃罗替尼游离碱单体10g、 丁酮lOOmL,启动搅拌，冰水冷却至-20〜-15。 In a clean, dry 250mL four-necked flask, into erlotinib free base monomer 10g, butanone lOOmL, start stirring, ice cooled to -20 to -15. C，开始緩慢滴加氯化氢浓度为2.0 moll/1的苯甲醚氯化氬溶液15.3mL,于0.5-1.5小时滴完，滴加毕，再保温3小时，保温毕，过滤，用10mL苯曱醚淋洗湿品，抽干后，放入20〜30。 C, hydrogen chloride slowly dropping argon anisole chloride solution 15.3mL 2.0 moll / 1 and to 0.5 to 1.5 hours after the dripping, dropping was completed, and then for 3 hours, complete insulation, filtered, washed with 10mL benzene 曱ether leaching wet product, after draining, add 20 to 30. C真空烘箱中千燥，得干品：10.5g，收率：96.1%。 C vacuum oven was dry, too dry goods: 10.5g, yield: 96.1%.
www.nixin.su/forum/turniry/671-posted-by...ceva-approval-europe
Patients receive selumetinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
In order to explore whether higher sensitivity to PD-L1 positive patients was related only to the concomitant presence of EGFR mutations or whether PD-L1 positive patients had a more indolent disease outcome when treated with EGFR-TKIs in presence of EGFR mutations, we further analysed the outcome of 54 EGFR mutated patients treated with gefitinib or erlotinib and evaluable for response. In this subgroup, although no difference in RR was detected (76.3 % vs 75.0 %. P = 1.00), PD-L1 positive ( N = 38, 70.4 % ) patients had a significantly longer TTP (13.1 months vs 8.5 months, P = 0.01) and a non significantly longer OS (29.5 months vs 21.1 months, P = 0.75) than PD-L1 negative ( N = 16, 29.6 % ) patients, as reported in Figure 5A and B .
About Tarceva Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in non-small cell lung cancer (NSCLC) and other solid tumors. HER1, also known as EGFR, is a component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC.
A recent study directly compared erlotinib with docetaxel and it found erlotinib is less effective at extending progression-free survival in patients whose tumours test negative for the EGFR-TK mutation.
Successful erlotinib treatment for a patient with gefitinib-related hepatotoxicity and lung adenocarcinoma refractory to intermittently administered gefitinib.
bezpeka.okht.net/index.php/forum/dobro-p...for-brain-metastases
Wie Tarceva aussieht und Inhalt der Packung
Insgesamt fehlen weiterhin Faktoren von prädiktiver und prognostischer Relevanz für die Therapie mit Erlotinib.
friendsknock.com/index.php?do=/blog/3633...tarceva-100-mg-pret/
Not taking Tarceva with food, as it may make the rash worse
From what I understand, Tarceva is used alone (not with chemo). 150 seems to be the regular "starting" dose, but could certainly be lower if the doctor felt it should be. And, it can always be dropped to a lower dose as treatment progresses if necessary. Tarceva works for some patients, and not for others. Even without the blood markers that indicate it is a match for trying it, Tarceva has still shown success in some of the other patients without the marker.
TARCEVA 150mg Erlotinib Film-Coated Tablets
Background: Erlotinib is FDA-approved for the first-line treatment of EGFR MT NSCLC, with a median progression free survival (PFS) of 10.4 months. Nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, demonstrated encouraging safety and survival outcomes as monotherapy in advanced NSCLC pts. Preclinical data support EGFR pathway activation of PD-L1 expression and immune escape in EGFR driven lung tumors. Interim results from a phase I study evaluating nivolumab + erlotinib in an EGFR MT advanced NSCLC cohort are reported. Methods: Stage IIIB/IV EGFR MT chemotherapy-naïve NSCLC pts (EGFR TKI naïve or progression post prior TKI therapy) received nivolumab 3 mg/kg IV Q2W + erlotinib 150 mg PO daily until progression/unacceptable toxicity. Objective response rate (ORR) and PFS were evaluated by RECIST 1.1. Results: All pts (n=21) began study treatment ≥10 months prior to data analysis; only 1 pt was EGFR TKI naïve. Any-grade treatment-related AEs were reported in all 21 pts; treatment-related grade 3–4 AEs (4 pts) were increased AST (n=2) or ALT (n=1), weight decrease and diarrhea (1 pt each); 2 pts discontinued due to treatment-related AEs (grade 3 AST increase and grade 2 nephritis). No pneumonitis (any grade) was observed. ORR was 19% (4/21 pts) and 24 wk PFS rate was 47%; median duration of response (DOR) was not reached (range 6.1+ to 27.1+ wks). Of the 20 pts with acquired erlotinib resistance, 3 (15%) achieved partial response (PR, all ongoing; DOR 6.1+, 16.3+ and 27.1+ wks); 9 pts (45%) had stable disease with 3/9 (33%) ongoing (time to progression/death 9.9+, 15.7, 21, 22.3, 24.4+, 31.1+, 35.9, 52.7 and 53 wks), and 1 pt had an unconventional “immune related” response (ongoing), with 46% reduction in target lesions after progression in non-target lesions. The EGFR TKI-naïve pt achieved PR with DOR 24.3+ wks (ongoing). Conclusions: These interim results suggest that nivolumab + erlotinib may provide durable clinical benefit and an acceptable safety profile in TKI refractory, EGFR MT advanced NSCLC, supporting further evaluation of nivolumab in pts with EGFR MT NSCLC. Additional follow up will be presented. Clinical trial information: NCT01454102.
ola eu tenho uma caixa do tarceva com 32 comprimidos com vencimento em maio de 2016 .sou de porto alegre,entre em contato comigo pelo watts 84167571
diplom.olandkar.by/index.php/forum/razde...eva-price-in-germany
Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5—5·Image may be NSFW.
Clik here to view.![8)]( "8)")
in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25—0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes.
Image may be NSFW.
Clik here to view.
Clik here to view.
*
Overall survival (OS) results from OPTIMAL (CTONG0802), a phase III trial of erlotinib (E) versus carboplatin plus gemcitabine (GC) as first-line treatment for Chinese patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).
In vitro assays of cytochrome P450 metabolism showed that erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2, and the extrahepatic isoform CYP1A1.
INTRODUCTION: Erlotinib drug is commonly known as HCl salt. It is also called as OSI-420 EGFR inhibitor . It is a small molecule of tyrosine kinase inhibitor that works against the receptor for epidermal growth factor. This epidermal growth factor results usually very high levels of expression and mostly gets mutated in case of various types of tumors, hence a valuable and attractive target for anti-tumor therapy [1]. One can order OSI-420 to any of the supplier OSI-420 . So one can purchase OSI-420 by paying Erlotinib price to its supplier that is around $65 for 1000 mg vial. Erlotinib structure describes that it has 2 rings of quinazoline. OSI-420 has found to be inhibiting the autophosphorylation of epidermal growth factor to render downstreaming of already stopped signaling cascade by binding to ATP binding site of EGFR in the reversible manner leading to a permanat change in its conformation or structure. Erlotinib solubility is 18 mg/ml in DMSO while it is very poorly soluble in water and ethanol. To inhibit EGFR tyrosine kinase enzyme in human, Erlotinib IC50 was found to be almost 20 nM [2]. OSI-420 EGFR inhibitor must be kept far away from different oxidizing agents so that it will remain stable and safe.
ea-me.de/index.php?do=/blog/63289/posted...rlotinib-rash-grade/
Erlotinib Carboxylic Acid
The metabolism of Erlotinib can be decreased when combined with Venlafaxine.
In conclusion, erlotinib has moderate efficacy for pretreated SCC in Japanese patients. Greater benefit can be expected in patients who develop a higher grade of skin rash. The incidence of ILD can be minimized by careful examinations to exclude pre-existing ILD. As our study is retrospective and the sample size is small, further prospective study is warranted to confirm the efficacy and safety of erlotinib (especially the incidence and severity of ILD) in Japanese SCC patients.
Erlotinib and pemetrexed have been approved for the second-line treatment of non-small cell lung cancer. Recent reports indicated that erlotinib and pemetrexed exerted synergistic effects against lung adenocarcinoma. The available treatment options for lung cancer with brain metastases (BM) are currently limited. In the present study, we investigated the efficacy of the combined administration of erlotinib and pemetrexed in 9 patients with epidermal growth factor receptor (EGFR) wild-type lung adenocarcinoma with BM. Pemetrexed (500 mg/m2) and cisplatin (20 mg/m2) were administered on day 1 and days 1-3, respectively. Erlotinib (150 mg) was administered daily on days 4-20. The 9 patients harbored EGFR wild-type mutation in the primary tumor tissues. With regard to the BM, no patients achieved complete remission, 7 patients exhibited a partial response (PR), 1 had stable disease (SD) and 1 had progressive disease (PD). As regards the extracranial tumors, 3 patients exhibited a PR, 2 had SD, 3 had PD and 1 was not applicable. The performance status and the symptoms improved in 3 patients following treatment. The median progression-free survival for intracranial and extracranial disease control was 179 and 146.5 days, respectively. The median overall survival was 197.4 days. Therefore, erlotinib combined with pemetrexed/cisplatin, was found to be effective in the treatment of patients with EGFR wild-type lung adenocarcinoma.
forum.drujba-konserv.com/viewtopic.php?p=12534#12534
Ik gebruik nu 3 jaar tarceva en het werkt bij mij geweldig, 4jaar geleden ben ik begonnen met chemo kuren maar het resultaat was 0, als laatste kon ik nog taceva proberen en dit werkte voor mij geweldig. Ik heb wel alle bijwerkingen gehad die op het lijstje staan en meer. Nog steeds heb ik veel last van mijn teennagels. Maar dat zijn kleinigheden zeker bij de mededeling va [lees meer. ] n de longarts 4 jaar geleden: u hebt nog 4 tot 6 maanden. Ik gebruik nu 3 jaar tarceva en het werkt bij mij geweldig, 4jaar geleden ben ik begonnen met chemo kuren maar het resultaat was 0, als laatste kon ik nog taceva proberen en dit werkte voor mij geweldig. Ik heb wel alle bijwerkingen gehad die op het lijstje staan en meer. Nog steeds heb ik veel last van mijn teennagels. Maar dat zijn kleinigheden zeker bij de mededeling van de longarts 4 jaar geleden: u hebt nog 4 tot 6 maanden.
The National Institute for Health and Clinical Excellence has published final draft guidance supporting Tarceva (erlotinib) as an option to treat patients with locally advanced or metastatic EFGR mutation-positive NSCLC.
Risk Summary Based on its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. When given during organogenesis, erlotinib administration resulted in embryo-fetal lethality and abortion in rabbits at doses approximately 3 times the recommended human daily dose of 150 mg. If Tarceva is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.11 )] .
erlotinib (150 mg PO QD) (Arm Image may be NSFW.
Clik here to view.
greekschool.ru/index.php/forum/razdel-pr...5-erlotinib-approval
Should I avoid certain foods while taking erlotinib?
在洁净干燥的250mL四口烧瓶中，投入埃罗替尼游离碱单体10g、 丁酮lOOmL,启动搅拌，冰水冷却至-20〜-15。 In a clean, dry 250mL four-necked flask, into erlotinib free base monomer 10g, butanone lOOmL, start stirring, ice cooled to -20 to -15. C，开始緩慢滴加氯化氢浓度为2.0 moll/1的苯甲醚氯化氬溶液15.3mL,于0.5-1.5小时滴完，滴加毕，再保温3小时，保温毕，过滤，用10mL苯曱醚淋洗湿品，抽干后，放入20〜30。 C, hydrogen chloride slowly dropping argon anisole chloride solution 15.3mL 2.0 moll / 1 and to 0.5 to 1.5 hours after the dripping, dropping was completed, and then for 3 hours, complete insulation, filtered, washed with 10mL benzene 曱ether leaching wet product, after draining, add 20 to 30. C真空烘箱中千燥，得干品：10.5g，收率：96.1%。 C vacuum oven was dry, too dry goods: 10.5g, yield: 96.1%.
www.nixin.su/forum/turniry/671-posted-by...ceva-approval-europe
Patients receive selumetinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
In order to explore whether higher sensitivity to PD-L1 positive patients was related only to the concomitant presence of EGFR mutations or whether PD-L1 positive patients had a more indolent disease outcome when treated with EGFR-TKIs in presence of EGFR mutations, we further analysed the outcome of 54 EGFR mutated patients treated with gefitinib or erlotinib and evaluable for response. In this subgroup, although no difference in RR was detected (76.3 % vs 75.0 %. P = 1.00), PD-L1 positive ( N = 38, 70.4 % ) patients had a significantly longer TTP (13.1 months vs 8.5 months, P = 0.01) and a non significantly longer OS (29.5 months vs 21.1 months, P = 0.75) than PD-L1 negative ( N = 16, 29.6 % ) patients, as reported in Figure 5A and B .
About Tarceva Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in non-small cell lung cancer (NSCLC) and other solid tumors. HER1, also known as EGFR, is a component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC.
A recent study directly compared erlotinib with docetaxel and it found erlotinib is less effective at extending progression-free survival in patients whose tumours test negative for the EGFR-TK mutation.
Successful erlotinib treatment for a patient with gefitinib-related hepatotoxicity and lung adenocarcinoma refractory to intermittently administered gefitinib.
bezpeka.okht.net/index.php/forum/dobro-p...for-brain-metastases
Wie Tarceva aussieht und Inhalt der Packung
Insgesamt fehlen weiterhin Faktoren von prädiktiver und prognostischer Relevanz für die Therapie mit Erlotinib.
friendsknock.com/index.php?do=/blog/3633...tarceva-100-mg-pret/
Not taking Tarceva with food, as it may make the rash worse
From what I understand, Tarceva is used alone (not with chemo). 150 seems to be the regular "starting" dose, but could certainly be lower if the doctor felt it should be. And, it can always be dropped to a lower dose as treatment progresses if necessary. Tarceva works for some patients, and not for others. Even without the blood markers that indicate it is a match for trying it, Tarceva has still shown success in some of the other patients without the marker.
TARCEVA 150mg Erlotinib Film-Coated Tablets
Background: Erlotinib is FDA-approved for the first-line treatment of EGFR MT NSCLC, with a median progression free survival (PFS) of 10.4 months. Nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, demonstrated encouraging safety and survival outcomes as monotherapy in advanced NSCLC pts. Preclinical data support EGFR pathway activation of PD-L1 expression and immune escape in EGFR driven lung tumors. Interim results from a phase I study evaluating nivolumab + erlotinib in an EGFR MT advanced NSCLC cohort are reported. Methods: Stage IIIB/IV EGFR MT chemotherapy-naïve NSCLC pts (EGFR TKI naïve or progression post prior TKI therapy) received nivolumab 3 mg/kg IV Q2W + erlotinib 150 mg PO daily until progression/unacceptable toxicity. Objective response rate (ORR) and PFS were evaluated by RECIST 1.1. Results: All pts (n=21) began study treatment ≥10 months prior to data analysis; only 1 pt was EGFR TKI naïve. Any-grade treatment-related AEs were reported in all 21 pts; treatment-related grade 3–4 AEs (4 pts) were increased AST (n=2) or ALT (n=1), weight decrease and diarrhea (1 pt each); 2 pts discontinued due to treatment-related AEs (grade 3 AST increase and grade 2 nephritis). No pneumonitis (any grade) was observed. ORR was 19% (4/21 pts) and 24 wk PFS rate was 47%; median duration of response (DOR) was not reached (range 6.1+ to 27.1+ wks). Of the 20 pts with acquired erlotinib resistance, 3 (15%) achieved partial response (PR, all ongoing; DOR 6.1+, 16.3+ and 27.1+ wks); 9 pts (45%) had stable disease with 3/9 (33%) ongoing (time to progression/death 9.9+, 15.7, 21, 22.3, 24.4+, 31.1+, 35.9, 52.7 and 53 wks), and 1 pt had an unconventional “immune related” response (ongoing), with 46% reduction in target lesions after progression in non-target lesions. The EGFR TKI-naïve pt achieved PR with DOR 24.3+ wks (ongoing). Conclusions: These interim results suggest that nivolumab + erlotinib may provide durable clinical benefit and an acceptable safety profile in TKI refractory, EGFR MT advanced NSCLC, supporting further evaluation of nivolumab in pts with EGFR MT NSCLC. Additional follow up will be presented. Clinical trial information: NCT01454102.
ola eu tenho uma caixa do tarceva com 32 comprimidos com vencimento em maio de 2016 .sou de porto alegre,entre em contato comigo pelo watts 84167571
diplom.olandkar.by/index.php/forum/razde...eva-price-in-germany
Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5—5·Image may be NSFW.
Clik here to view.
in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25—0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes.