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Studies Lead to Big Changes in Lung Cancer Treatments

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http://www.nytimes.com/2005/06/23/healt ... r=homepage

June 23, 2005

Studies Lead to Big Changes in Lung Cancer Treatments


For the first time in decades, doctors have begun making major changes in the treatment of lung cancer, based on research proving that chemotherapy can significantly lengthen life for many patients for whom it was previously thought to be useless.

The shift in care applies to about 50,000 people a year in the United States who have early cases of the most common form of the disease, non-small-cell lung cancer, and whose tumors are removed by surgery. Many of these patients, who just a few years ago would have been treated with surgery alone, are now being given chemotherapy as well, just as it is routinely given after surgery for breast or colon cancer. The new approach has brightened a picture that was often bleak.

"The benefit is at least as good, and maybe better than in the other cancers," said Dr. John Minna, a lung cancer expert and research director at the University of Texas Southwestern Medical Center in Dallas. He said new discoveries were helping to eliminate doctors' "nihilistic" attitudes about chemotherapy for lung cancer.

"The standard of care has changed," said Dr. Christopher G. Azzoli, a lung cancer specialist at Memorial Sloan-Kettering Cancer Center in New York.

A major impetus for the change came a year ago, when two studies presented at a cancer conference showed marked increases in survival in patients who received adjuvant chemotherapy, meaning the drugs were given after surgery. In one study of 482 patients in Canada and the United States, led by Dr. Timothy Winton, a surgeon from the University of Alberta, 69 percent of patients who had surgery and chemotherapy were still alive five years later, as compared with 54 percent who had just surgery. The patients were given a combination of two drugs, cisplatin and vinorelbine, once a week for 16 weeks.

In the world of lung cancer research, a survival difference of 15 percentage points is enormous. Over all, the patients given chemotherapy lived 94 months, versus 73 months in those who had only surgery - also a huge difference in a field in which a treatment is hailed as a success if it gives patients even three or four extra months.

A second study, also announced at the conference last year, had similar findings, and so did a third, presented just a month ago at the annual meeting of the same cancer group, the American Society of Clinical Oncology.

At major medical centers, doctors quickly began to put the results into practice.

"The findings were so stunning from these studies a year ago that they began to change the standard of care," said Dr. Pasi Janne, a lung cancer specialist at the Dana Farber Cancer Institute in Boston. "Over the last year, the number of patients we've had referred here for adjuvant chemotherapy has gone up steadily."

But some doctors hesitated to make changes, Dr. Winton said, wanting first to see the studies published in a medical journal, which would mean the data had stood up to the scrutiny of editors and expert reviewers.

Now, his study has become the first of the three to pass that test. It is being published today in The New England Journal of Medicine, along with an editorial by Dr. Katherine M. S. Pisters, a lung cancer specialist at the M. D. Anderson Cancer Center in Houston.

Dr. Pisters wrote that Dr. Winton's results were "astonishing," had "tremendous implications" and would end the controversy that had existed about whether chemotherapy could help people with lung cancer.

"There was a remarkable improvement in survival," she said in a telephone interview, adding that lung cancer experts had never seen anything like it before. "No question, the debate is over."

Patients in the study did suffer from side effects, including lowered blood counts, fatigue, nausea, vomiting, nerve damage and constipation. Generally, the reactions were not severe, though two patients (0.8 percent) died from toxic effects - not an unexpected finding with the powerful drugs used to treat cancer.

Dr. Pisters said that the oncology society and the American College of Chest Physicians were both rewriting their formal guidelines to say chemotherapy should be given after surgery for early-stage lung tumors like the ones in the studies.

She and Dr. Azzoli said that although medical oncologists, the cancer doctors who prescribe chemotherapy, knew about the lung-cancer findings, surgeons and internists may not have heard about or accepted them.

Dr. Azzoli said: "We also want the surgeons to be aware of this data, because they are the ones who need to refer patients to the medical oncologists. Until this point, they would not necessarily refer people. Now, they have to."

Worldwide, lung cancer is the most common cancer and the leading cause of cancer death, with more than a million new cases and a million deaths every year. In the United States, it is expected to kill 163,510 people this year - more than breast, prostate and colon cancer and leukemia combined. Nearly all the cases are caused by smoking.

From 80 percent to 85 percent of lung cancers are the type that Dr. Winton studied, non-small-cell cancers. His findings apply to 25 percent to 30 percent of newly diagnosed cases, those that can be removed surgically and are at an early point in the disease classified as Stage IB or Stage II.

With surgery alone, five-year survival ranges from 23 percent to 67 percent, depending on the size of the tumor and how much it has begun to spread, according to Dr. Pisters. From the 1960's through the mid-1990's, efforts to better the odds with chemotherapy failed. Not only did the drugs not help, they sometimes hurt, actually shortening patients' lives instead of extending them. And so for many years, patients with early tumors were advised to have surgery and no other treatment. Many relapsed and died. Chemotherapy for advanced lung cancer cannot cure it.

But new chemotherapy drugs were being introduced, along with better medicines for side effects like nausea and low blood counts. Dr. Winton began his study in 1994. It was paid for by the governments of Canada and the United States, and by GlaxoSmithKline, which makes vinorelbine. Dr. Winton said the company did not control the data in any way.

The two drugs fight cancer in different ways. Dr. Winton said, "It's a collective attack on two different components of cell division and growth that has made this doublet effective in this disease."

Thomas Blowers, 69, a retired research director for public schools in Edmonton, Alberta, had surgery to remove two-thirds of his right lung five years ago, followed by chemotherapy as part of the study. He suspected the treatment helped him, because he knew other people with lung cancer who did not enter the study and, he said, "they don't live very long at all."

"I'm still alive," Mr. Blowers said. "I say any day you're breathing in and out is a good day."

Other drug combinations can also be used, Dr. Pisters said, as long as one is a platinum-based drug like cisplatin or carboplatin.

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When I was first diagnosed-and after my first surgery-I BEGGED for chemotherapy.

They WOULD NOT GIVE IT TO ME. Not even after the second surgery.

I honestly believe that I was put into one of the

"random studies" being done to prove/disprove the effectiveness of chemo after surgery for Lung Cancer. In a randomized study the patients are put into one of two or more groups who are "offered" certain treatments...problem is that study participants are supposed to be notified and given the choice to accept or decline participation. And if a patient specifically REQUESTS a treatment that is appropriate it should be provided.

Bottom line is I believe I was put into a random study without notification and against my specific and known wishes.And I was in the group which was not given the benefit of chemo.

I know that in order for researchers to determine if a protocol works it must be tested...But there is the question of ethics. And ethics demands that participants be notified and given the choice to refuse to be a test subject.

I believed all along that chemo after surgery would improve my chances of time without disease recurrence and/or spread. Nice to know my instincts are good. Sorry as heck my docs at the time didn't feel that I was worthy of their best efforts.

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