Earlier Findings Showed That Alimta+Cisplatin Helped These Same Patients Live Longer

SOURCE: Eli Lilly and Company

Thoracic Expert: Patients With Asbestos-Related Cancer Report Better Quality of Life With Alimta+Cisplatin

CHICAGO--(BUSINESS WIRE)--June 2, 2003-- Patients enduring an agonizing form of cancer often associated with asbestos exposure reported that the combination of Alimta ® (pemetrexed) and cisplatin enabled them to enjoy a better overall quality of life, compared to cisplatin alone.

The findings - unveiled today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago - come on the heels of data presented at last year's ASCO meeting indicating that Alimta+cisplatin enabled these same exact patients to live longer than if they received cisplatin alone.

"Patients with advanced cancer should not have to choose between feeling better and living longer," said Richard Gralla, M.D., a noted thoracic cancer expert and president of the New York Lung Cancer Alliance, who presented the findings. "Patients, and we as health care professionals, want both."

Gralla characterized the findings as "very good news" in developing a potential treatment for malignant pleural mesothelioma, a disease in which a tumor - caused by asbestos fibers - lodges between the chest wall and lung cavity. "This is a terrible disease with a high mortality rate and is associated with several debilitating symptoms, including crushing chest pain and difficulty breathing," said Paolo Paoletti, M.D., vice president of oncology products at Eli Lilly and Company, which is developing Alimta.

At least 10,000 people worldwide are diagnosed with malignant pleural mesothelioma each year, according to conservative estimates. However, that figure is expected to increase because malignant pleural mesothelioma has a long latency period - 20 to 50 years. There is currently no approved therapy for this disease.

The survival and quality of life data for Alimta resulted from a Phase III randomized study of 448 patients with malignant pleural mesothelioma from 19 countries. Of these patients, 226 received Alimta + cisplatin (a common chemotherapeutic agent) and 222 received cisplatin only.

As previously reported, results showed that combining Alimta with cisplatin increased patients' median survival by 30 percent (12.1 vs. 9.3 months, a finding that was statistically significant). No other chemotherapy studied in malignant pleural mesothelioma, including cisplatin alone, has been able to exceed the six-to-nine month life expectancy for patients diagnosed with this disease.

The quality of life data were reported in detail today for the first time. The data were obtained from the same 448 patients who were tracked for survival.

According to this analysis, patients treated with a combination of Alimta and cisplatin experienced significantly less pain and difficulty breathing, among other symptoms. "Not only is their life prolonged by this treatment, but their quality and enjoyment of it is improved," said Michael Boyer, M.D., head of the department of medical oncology at the Sydney Cancer Center in Australia. "People who were no longer able to do the things they enjoy are once again able to participate in life."

More About The Study

In this study, 77 percent of patients had Stage III-IV, or advanced, disease.

The study's primary endpoint was survival. Quality of life, which takes into account a patient's physical, psychological and social functioning, was a secondary endpoint.

In gathering quality of life data, researchers used an instrument known as the LCSS- Meso Scale. This scale is based on the Lung Cancer Symptom Scale (LCSS), a validated and widely used instrument for measuring quality of life in patients with lung cancer.

In addition to rating their overall level of quality of life, patients were also asked to rate five specific symptoms associated with their disease: pain, shortness of breath, fatigue, appetite loss, and cough. At least 90 percent of patients stated they had at least three of these symptoms.

According to the results, all comparisons favored the Alimta+cisplatin arm versus the cisplatin-alone arm. In particular, patients reported that the extent of their pain, shortness of breath and cough was significantly better by week 12, or after four cycles of treatment with Alimta+cisplatin, compared to cisplatin alone. These improvements persisted through two other measured periods of time: week 15 (five cycles of treatment) and week 18 (six cycles of treatment). In this study, evaluation was completed at the end of week 18.

Patients' level of fatigue was significantly better by week 15 and lasted through week 18 (the end of the evaluation period). In sum, according to the researchers, by week 18, significantly more patients on the Alimta+cisplatin arm reported better quality of life compared to patients on cisplatin only. As with the findings on survival, these results reached the level of statistical significance (p= 0.012).

The most common side effect of Alimta+cisplatin therapy observed in this 448-patient study was a decrease in white blood cell counts (technically known as neutropenia), but the rate of serious infection was very low. The severity of neutropenia, as well as other side effects, including diarrhea and painful mouth ulcers, was significantly ameliorated by folic acid and vitamin B12 supplementation.

In the United States, Alimta is in the process of a rolling submission to the U.S. Food and Drug Administration (FDA) for use, with cisplatin, in the treatment of malignant pleural mesothelioma. In the meantime, in cooperation with the FDA, Lilly has provided Alimta free of charge to more than 600 patients with mesothelioma as part of an expanded access, or compassionate use, program. Similar programs are underway in other countries around the world as well. "This is simply the right thing to do," said Paoletti. "Until now, patients could really only look forward to a steady downhill course. Now, patients with malignant pleural mesothelioma have access to a treatment that offers a chance of having an impact on the course of their disease."