New Treatment Approach Gives Patients With Incurable Lung Cancer More Time Without Disease Progression Compared To Placebo

Main Category: Lung Cancer
Also Included In: Cancer / Oncology
Article Date: 05 Jun 2009 - 0:00 PDT

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Results from a Phase III study presented at the American Society for Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida today show that patients with advanced non-small cell lung cancer (NSCLC) who received erlotinib (Tarceva®) as first-line maintenance treatment benefited from a significant (29%) improvement in the time they lived without the disease advancing, compared with those who received placebo1. Patients in the global multicentre SATURN trial, which included patients from the UK, received maintenance treatment with erlotinib if their cancer had not progressed on initial chemotherapy. The data showed a significant improvement in the length of time patients lived without their disease getting worse, and without the need for further chemotherapy. 1 The improvement was seen in both of the main types of NSCLC (squamous cell as well as non-squamous cell) and these results form the basis of a submission for regulatory approval of erlotinib to be used in the first-line maintenance setting. 1 Erlotinib is not currently licensed for first line maintenance treatment in NSCLC lung cancer in the UK.

Commenting on the study results, Dr Conrad Lewanski, Consultant Oncologist at Imperial Healthcare NHS Trust, London, said: "SATURN brings welcome news for NSCLC patients in the UK and their families, and represents a new milestone in the treatment of the disease. Stopping the cancer growing for as long as possible reduces symptoms and helps improve the patient's life. Being able to achieve these benefits without the need for chemotherapy is important since the side effects of chemotherapy add considerably to the physical and psychological burden of cancer for many patients."

NSCLC progresses rapidly and less than 5% of advanced NSCLC patients survive for five years2. Extending the time patients live without their disease progressing whilst managing side effects are key treatment goals. Erlotinib is already approved for use by NICE3 and the SMC4 as an alternative to chemotherapy in second-line treatment in patients whose cancer returns following chemotherapy, giving patients the choice of an oral, well tolerated treatment. These new data show erlotinib to be effective in delaying progression of the disease in NSCLC patients who do respond to chemotherapy.

Study shows 'biomarkers' could help tailor treatment

Important results from tissue samples collected as part of the SATURN study protocol have provided important information on the potential role of biomarkers, such as EGFR and K-ras mutations, in predicting possible outcomes of erlotinib therapy in NSCLC patients. An analysis of patients whose tumours possessed an activating EGFR mutation (a small difference in the structure of the EGFR protein found on the surface of the cancer cell) demonstrated a significantly more pronounced increase in the time patients live without their disease worsening than in the majority of patients with unmutated (or "wild type") EGFR.

"Non-chemotherapy treatment options are much needed in the maintenance setting in NSCLC," continued Dr Lewanski. "The results of the SATURN study mean that erlotinib has the potential to play a particularly effective role for patients whose tumours have an EGFR mutation. Other patients, including those with a squamous cell histology, also may now have an alternative therapeutic option."

Lung cancer is the biggest cancer killer in the UK and is responsible for almost a quarter of all cancer deaths5. There are over 38,000 new cases of lung cancer diagnosed in the UK each year6, which amounts to one person being diagnosed every 15 minutes7. Almost as many people die of lung cancer as breast, colorectal and prostate combined8, and NSCLC accounts for approximately 80% of lung cancer cases9.

Adverse events seen in the SATURN study were consistent with previous erlotinib studies and no new safety signals were observed. The most common side effects are rash and diarrhoea10. Erlotinib is not currently licensed in the UK for use in the first-line maintenance setting in NSCLC.

Study background and key results

SATURN

A global multicentre, double blind, randomised, prospective Phase III study to evaluate the efficacy of erlotinib or placebo in patients with advanced, recurrent or metastatic NSCLC who had not progressed following first line platinum based chemotherapy. The study involved more than 880 patients from approximately 160 centres; 438 received erlotinib and 451 placebo. The study met its primary endpoint demonstrating a statistically significant extension of the time patients live without their disease worsening; there was a 29% increase compared with placebo (hazard ratio= 0.71. p-value <0.0001).

About Tarceva

Erlotinib is a once-daily oral targeted treatment licensed in the UK in September 2005 for the treatment of patients with locally advanced or metastatic (spreading through the body) NSCLC after failure of at least one prior chemotherapy regimen. It is not currently licensed for the treatment of first line maintenance treatment. It has been shown to reduce the debilitating side-effects of lung cancer and increase the number of relapsed patients alive at one year by 42% when compared to best supportive care alone10. It targets the Epidermal Growth Factor Receptor (EGFR) which is associated with cancer cell growth. In the pivotal BR.21 trial, around 15% of patients lived beyond two years10 - an unprecedented result for this disease area. The most common side effects are rash and diarrhoea, although patients reported less pain and coughing compared to best supportive care alone10. Erlotinib was approved as a clinically and cost-effective alternative to docetaxel by NICE in October 20083, and prior to that was approved by the SMC for use on the NHS in Scotland in June 20064. Since its initial launch four years ago, Tarceva has been used to treat more than 250,000 patients and has been approved in over 80 countries worldwide11.

References

1. Cappuzzo F et al. Abstract 8001 presented at ASCO 2009 Annual Meeting, Orlando, US

2. Allen J et al. J Natl Compr Canc Netw 2008;6(3):285-9

3. National Institute for Health and Clinical Excellence. Lung cancer (non-small-cell) - erlotinib Final Guidance. Available from here.
4. Scottish Medicines Consortium. Erlotinib (Tarceva®) (Resubmission) - Roche 12 June 2006. Available here.

5. Cancer Research UK © 2008. UK cancer mortality statistics for common cancers [Updated March 2009, accessed 2009 May 27]. Available here.

6. Roy Castle Lung Cancer Foundation © 2008. Lung Cancer Facts & Figures [Updated 2009, accessed 2009 May 27]. Available here.

7. Cancer Research UK © 2008. UK lung cancer mortality statistics [Updated 27 April 2009, accessed 2009 May 27]. Available here.

8. United Kingdom Lung Cancer Coalition © UKLCC 2006. Lung Cancer - The Facts. [Accessed 2009 May 27] Available here.

9. Roy Castle Lung Cancer Foundation © 2007. Types of lung cancer [Updated 2009, accessed 2009 May 27]. Available here.

10. Shepherd FA, Pereira JR, Ciuleanu T et al. Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005; 353(2):123-32

11. Roche Products Ltd. Data on file

Source
Roche