Gefitinib Improves Survival In Lung Cancer Patients With Mutated EGF

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Gefitnib is back after experiencing difficulties in treating generalized

population of NSCLC (1). It appears after some data mining additional trials

were ran to look specifically at a couple of these NSCLC subgroups.

A study conducted in 2006 involved 1,217 patients in advanced stages of cancer

who had not previously received chemotherapy, and who had never smoked or who

had smoked very little. The results showed 25 percent of patients on gefitinib

had no cancer growth within 12 months, compared with 7 percent on chemotherapy.

Final overall survival data from this study will not be available until 2010,

but the median overall survival is slightly better with gefitinib than with

chemotherapy.(1)(2). As it turns out the mutated form of EGFR is more

prevailent in above group(1) and may explain the improved results considering

the findings in the next trial below.

The following is copied from an article found on the `Drug Discuvery &

Development' website(3)

Gefitinib Improves Survival in Lung Cancer PatientsDrug Discovery & Development

- December 21, 2009 Patients with the most common form of lung cancer

(non-small-cell lung cancer) who have mutations in the epidermal growth factor

receptor (EGFR) gene have significantly improved progression-free survival if

they are treated with gefitinib compared with standard chemotherapy. Wherever

possible, EGFR genetic testing must be done and gefitinib should be considered

as the first-line treatment for patients with EGRF mutations, concludes an

Article published Online First in The Lancet Oncology.

Non-small-cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases,

and remains the leading cause of cancer death worldwide. Recently, targeted

drugs have been developed that can improve survival in specific groups of

patients with NSCLC. For example, gefitinib has been shown to have considerable

benefit in patients with NSCLC who are more likely to have EGFR mutations, such

as those of Asian origin, women, and those who have never smoked. Recent trials

of gefitinib monotherapy have failed to show any survival advantage in

unselected patient populations. It has been suggested that this lack of survival

advantage might be due to a lack of patient selection.

To resolve this uncertainty, Tetsuya Mitsudomi and colleagues from West Japan

Oncology Group compared gefitinib with a standard chemotherapy regimen

(cisplatin plus docetaxel) in patients with NSCLC selected according to EGRF

mutation status. 177 patients with EGFR mutations were recruited from 36 centres

in Japan and randomly assigned to receive either gefitinib (88) or cisplatin

plus docetaxel (89) every 21 days for 3 to 6 cycles. Disease progression was

regularly assessed using CT and MRI.

Overall, patients in the gefitinib group had significantly longer

progression-free survival (9.2 months) compared with the chemotherapy group (6.3

months).

In addition, findings showed that the objective response rate* was significantly

higher in the gefitinib group (62.1%) than in the cisplatin plus docetaxel group

(32.2%). The disease control rate was also higher in the gefitinib group (93.1%)

than in the chemotherapy group (78%).

Gefitinib was also generally better tolerated than cisplatin plus docetaxel, and

adverse events of grade 3 or more were infrequent and included skin rash, liver

dysfunction, and diarrhoea. By contrast, the most common adverse events in the

chemotherapy group occurred in more than half of patients and included nausea,

myelosuppression, fatigue, and alopecia.

The authors say: " Our study indicates that EGFR genetic testing is feasible and

should be done when possible…Considering the efficacy and toxicity of gefitinib,

it is a reasonable option for the first-line treatment of patients with

activating EGFR mutations. "

They conclude: " These results strongly suggest that the presence of EGFR

mutations, and not the clinical background of patients, determines clinical

efficacy, and this knowledge should lead to molecularly based, personalised

treatment of lung cancer in the near future. "

Date: December 21, 2009

Source: Lancet(4)