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The pharmaceutical company, Pfizer, announced that its lung cancer drug, dacomitinib, is not effective in treating non-small cell lung cancer, contrary to the company’s initial speculation and hope for the medication.
Non-small cell lung cancer, abbreviated NSCLC, comes in three forms: large cell carcinoma, adenocarcinoma, and squamous cell carcinoma.
While Pfizer was optimistic about how dacomitinib, its NSCLC medication, could help patients, the drug has proven ineffective for lung cancer treatment, but since chemotherapy rarely works to treat NSCLC, the results are not shocking to the cancer treatment community.
Currently, treatment for non-small cell lung cancer involves surgery, if the location of the cancer is operable, and if not, then patients are given erlotinib (brand name Tarceva), an oral medication, manufactured by the pharmaceutical company, Roche Holding AG. Pfizer hoped to revolutionize the treatment of NSCLC with its drug, dacomitinib, but patients in Phase I and Phase II of the studies responded better to erlotinib than to Pfizer’s dacomitinib. The current drug, erlotinib is only able to inhibit one form of EGFR, so if another site is responsible for the abnormal cell behavior, the drug will not work. Although the drug is proving ineffective, Pfizer will continue on with Phase III testing of its lung cancer drug, dacomitinib, on patients diagnosed with NSCLC, who have not received any other form of treatment thus far, to see if the medication is effective for those with advanced non-small cell lung cancer. Signs of non-small cell lung cancer include a cough that doesn't go away and shortness of breath. Tests that examine the lungs are used to detect (find), diagnose, and stage non-small cell lung cancer. A thin membrane called the pleura covers the outside of each lung and lines the inside wall of the chest cavity. The pleural cavity normally contains a small amount of fluid that helps the lungs move smoothly in the chest when you breathe.
There are two main types of lung cancer: non-small cell lung cancer and small cell lung cancer.
Other less common types of non-small cell lung cancer are: pleomorphic, carcinoid tumor, salivary gland carcinoma, and unclassified carcinoma.
Tests and procedures to detect, diagnose, and stage non-small cell lung cancer are often done at the same time.
Physical exam and history : An exam of the body to check general signs of health, including checking for signs of disease, such as lumps or anything else that seems unusual.
Laboratory tests : Medical procedures that test samples of tissue, blood, urine, or other substances in the body. CT scan (CAT scan): A procedure that makes a series of detailed pictures of areas inside the body, such as the chest, taken from different angles. Sputum cytology : A procedure in which a pathologist views a sample of sputum (mucus coughed up from the lungs) under a microscope, to check for cancer cells. Fine-needle aspiration (FNA) biopsy of the lung: The removal of tissue or fluid from the lung using a thin needle. Bronchoscopy : A procedure to look inside the trachea and large airways in the lung for abnormal areas.
Thoracoscopy : A surgical procedure to look at the organs inside the chest to check for abnormal areas. Thoracentesis : The removal of fluid from the space between the lining of the chest and the lung, using a needle. Light and electron microscopy : A laboratory test in which cells in a sample of tissue are viewed under regular and high-powered microscopes to look for certain changes in the cells. Immunohistochemistry : A test that uses antibodies to check for certain antigens in a sample of tissue.
Whether the cancer has mutations (changes) in certain genes, such as the epidermal growth factor receptor (EGFR) gene or the anaplastic lymphoma kinase (ALK) gene. When you are told you have lung cancer and begin looking for treatment options, you may be concerned about life expectancy and quality of life. The chart below shows the cancer survival rates of 199 metastatic small cell lung cancer patients who were diagnosed between 2000 and 2009.
Of the CTCA metastatic small cell lung cancer patients shown in the above chart, the estimated survival rate at six months was 82%. SEER is the only authoritative source of population-based information about cancer incidence and survival in the United States that includes the stage of cancer at the time of diagnosis and patient survival data. The objective of this analysis was to see how long each group of patients survived after their diagnosis.
The independent biostatistician computed the survival outcomes of metastatic small cell lung cancer patients from the CTCA database and metastatic small cell lung cancer patients from the SEER database who were diagnosed between 2000 and 2009. The chart below shows the cancer survival rates for a group of 250 metastatic small lung cancer patients who were diagnosed between 2000 and 2011. Of the CTCA metastatic small cell lung cancer patients shown in the above chart, the estimated survival rate at six months was 75%.
At Cancer Treatment Centers of America, we understand that you may also wish to see the survival rates of the group of metastatic small cell lung cancer patients reported in the Surveillance, Epidemiology and End Results (SEER) database of the National Cancer Institute. Therefore, we asked an independent biostatistician to analyze both the survival rates of the group of CTCA patients and the group of patients included in the SEER database. We also want to be sure you understand that cancer is a complex disease and each person’s medical condition is different; therefore, CTCA makes no claims about the efficacy of specific treatments, the delivery of care, nor the meaning of the CTCA and SEER analyses. This analysis included small cell lung cancer patients from CTCA who were diagnosed from 2000 to 2011 (including 2000 and 2011) with primary tumor sites (as coded by ICD-O-2 (1973+)) from C340 to C343, and were considered analytic cases by the CTCA. Primary tumor sites (as coded by ICD-O-2 (1973+)), date of initial diagnosis, date of last contact, year of initial diagnosis, age of initial diagnosis, gender, vital status, and cancer histologic type as coded by the ICD-O-3.
The database from the CTCA cohort was prepared by the CTCA cancer registrars from the following four hospitals: Southwestern Regional Medical Center hospital, Midwestern Regional Medical Center hospital, Eastern Regional Medical Center hospital, and Western Regional Medical Center hospital. The SEER program of the National Cancer Institute is an authoritative source of information on cancer incidence and survival in the United States.


This analysis included small cell lung cancer patients from the latest SEER Limited-Use Database (as of 2014) who were diagnosed from 2000 to 2011 (including 2000 and 2011) with primary tumor sites (as coded by ICD-O-2 (1973+)) from C340 to 343.
Primary tumor sites (as coded by ICD-O-2 (1973+)), survival time recode as calculated by the date of initial diagnosis and the date of death or the follow-up cutoff date, year of initial diagnosis, age of initial diagnosis, gender, vital status, and cancer histologic type as coded by the ICD-O-3. In order to make a meaningful survival analysis, basic cancer and patient characteristics such as age at initial diagnosis, year of initial diagnosis, cancer stages, cancer primary sites, and gender were first analyzed for both the CTCA and SEER samples.
For example, if a specific primary tumor site had patients in only one database, none of those patients were used in the analysis. The survival outcome from the CTCA database was defined as the time from the initial diagnosis to death and computed in number of years as the difference between the date of death and the date of initial diagnosis divided by 365.25. For each survival outcome from each database, the survival curve, defined as the probability of cancer patient survival as a function of time after the initial diagnosis, was estimated by the nonparametric product-limit method[1]. Covariates such as age at initial diagnosis and year of initial diagnosis could affect the survival of small cell lung cancer patients. We understand you may be feeling overwhelmed with questions and concerns about your type of cancer and what it all means. Explore our cancer hospitals, which house the latest treatments, technologies and integrative oncology services under one roof. Discover our patient-centered approach, and how you get all your questions answered in a single visit by a dedicated team of cancer experts.
These and other signs and symptoms may be caused by small cell lung cancer or by other conditions. CT scan (CAT scan) of the brain, chest, and abdomen : A procedure that makes a series of detailed pictures of areas inside the body, taken from different angles. Biopsy : The removal of cells or tissues so they can be viewed under a microscope by a pathologist to check for signs of cancer.
The stage of the cancer (whether it is in the chest cavity only or has spread to other places in the body).
For certain patients, prognosis also depends on whether the patient is treated with both chemotherapy and radiation. After a series of studies, Pfizer concludes that dacomitinib does not reduce the progression of cancer in patients who are taking the drug. While these types of lung cancer are often developed in people who smoke cigarettes, the presence of NSCLC is not limited to those who smoke. Non-small cell lung cancer, the most common form of lung cancer, is often unresponsive to radiation and chemotherapy and, therefore, requires a different approach to treatment. However, a new drug to reduce NSCLC would have helped a lot of people suffering from the disease.
Cancer experts believe that when lung cancer has altered certain proteins in a person’s body, which regulate the natural growth of cells, abnormal cell multiplication occurs and cancer cells are formed. Results are expected some time in 2015 and while the Chief Medical Officer for Pfizer Oncology, Dr. Having a risk factor does not mean that you will get cancer; not having risk factors doesn’t mean that you will not get cancer. A history of the patient’s health habits, including smoking, and past jobs, illnesses, and treatments will also be taken. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.
The antibody is usually linked to a radioactive substance or a dye that causes the tissue to light up under a microscope.
At Cancer Treatment Centers of America® (CTCA), we believe you have the right to know our statistics for lung cancer treatment outcomes, so you can choose the best cancer care for you and your family.
Therefore, we asked an independent biostatistician to analyze the survival results of CTCA® patients. This means that six months after their diagnosis, 82% of the patients in this group were still living. Therefore, we asked the same independent biostatistician to analyze both the survival rates of CTCA patients and those of patients included in the SEER database.
Therefore, SEER is currently the most comprehensive database for the analysis of CTCA results and national results.
Our fifth hospital, located near Atlanta, Georgia, was not included because it was not open to patients until August 2012. Across all the 11 cancer types whose survival results are presented on the CTCA website, 0.48% of the CTCA patients included in the analyses were only diagnosed by CTCA and received no initial course of treatment from CTCA. In both cases, the patients had been diagnosed with metastatic or distant cancer – cancer that had traveled from the primary site (lung) to one or more distant sites in the body where it continued to grow. These factors significantly reduced the size of the CTCA sample, which means that the estimates reflected in the survival chart may be subject to high variation and may not be replicated in the future when we have a larger CTCA sample for analysis.
Not all cancer patients who are treated at a CTCA hospital may experience these same results. This means that six months after their diagnosis, 75% of the patients in this group were still living. SEER is a source of population-based information about cancer incidence and survival in the United States that includes the stage of cancer at the time of diagnosis and patient survival data. The independent biostatistician computed the survival outcomes of metastatic small cell lung cancer patients from the CTCA database and metastatic small cell lung cancer patients from the SEER database who were diagnosed between 2000 and 2011. More specifically, the SEER Limited-Use Database contained a combination of three databases. The survival outcome from the SEER database was provided by the SEER Limited-Use Data File as the number of completed years and the number of completed months. Formal statistical analyses of the small cell lung cancer survival distributions between the CTCA database and the SEER database were conducted by the nonparametric logrank test and Wilcoxon test as well as the likelihood ratio test[1].


Similar estimates were also computed to estimate the difference of the survival rates at these time points between the two cohorts. Therefore, additional adjusted analyses were completed on the survival outcomes between the CTCA and SEER samples after adjusting for the effects of these covariates.
First, although a large cancer sample was available from the SEER program across many geographic regions in the United States, both samples, including the sample from CTCA, are convenience samples. These tests help to diagnose disease, plan and check treatment, or monitor the disease over time. A CT scan, ultrasound, or other imaging procedure is used to find the abnormal tissue or fluid in the lung.
A bronchoscope is inserted through the mouth, trachea, and major bronchi into the lung, to look for abnormal areas. The process includes Epidermal Growth Factor Receptors (EGFR), the site of protein mutations that are linked to various forms of cancer, and the intended recipient of dacomitinib, formulated to attack several forms of EGFR. Cancer can be treated by surgery, chemotherapy, radiation therapy and monoclonal antibody therapy.
Oxygen is inhaled into the lungs and passes through the thin membranes of the alveoli and into the bloodstream (see inset).
A dye may be injected into a vein or swallowed to help the organs or tissues show up more clearly. A similar statistic for metastatic small cell lung cancer alone is not currently available. SEER collects information on cancer incidence, prevalence and survival from specific geographic areas that represent 28% of the population of the United States. In both cases, the patients had been diagnosed with distant (metastatic) cancer as discussed above. The SEER Program is a comprehensive source of population-based information in the United States that includes stage of cancer at the time of diagnosis and patient survival data. Patients whose age at initial diagnosis fell into the overlap of the two ranges from the CTCA and SEER samples were included in the survival analysis.
These were then converted to the number of years by dividing the number of total months by 12. Because the estimated survival curves might not estimate the survival probability at these specific time points, survival rates from the closest observed survival times were used.
The nature of these convenience samples prevents a causal interpretation of the statistical inferences. A small incision may be made in the skin where the biopsy needle is inserted into the abnormal tissue or fluid.
Mediastinoscopy : A surgical procedure to look at the organs, tissues, and lymph nodes between the lungs for abnormal areas. This procedure is also called computed tomography, computerized tomography, or computerized axial tomography. It may also have a tool to remove tissue samples, which are checked under a microscope for signs of cancer.EnlargeBronchoscopy. It is also possible that the SEER database may contain some of the CTCA cancer cases that were part of the analysis. This means the cancer had traveled from the primary site (lung) to one or more distant sites in the body where it continued to grow. For these patients who were still alive or lost to follow-up at the time of entering the databases, their survival time was treated as statistically censored[1] at the difference between the date of last contact and the date of initial diagnosis. Because five-year survival rates have been popularly used in many cancer survival reports, five-year survival curves were also obtained by treating those who survived more than five years after the initial diagnosis as statistically censored at five years. Second, although some types of matching, as described above, were implemented to select the appropriate SEER and CTCA comparison samples, the distributions of important covariates such as age at initial diagnosis, race and year of initial diagnosis were not exactly the same between the CTCA sample and SEER sample. The chemical composition of dacomitinib aims at permanently altering what are called human epidermal receptors (HER) and EGFRs to interfere with abnormal cell division and transformation.
Because patients surviving more than five years remained part of the risk sets in the estimation of survival rates at any time within five years of diagnosis, the truncated survival curves were identical to the first portion of the complete survival curves. Hence, even with the adjusted analyses, the possible confounding of these factors to the analyses and results cannot be ruled out. Another Cox proportional hazards model was also used to simultaneously adjust for the effects of both covariates (age at diagnosis and year of initial diagnosis) in the survival analysis.
A chest x-ray is done after the procedure to make sure no air is leaking from the lung into the chest.EnlargeFine-needle aspiration biopsy of the lung.
The patient lies on a table that slides through the computed tomography (CT) machine, which takes x-ray pictures of the inside of the body.
It may also have a tool to remove tissue or lymph node samples, which are checked under a microscope for signs of cancer. Third, the survival analyses were based on the statistical comparisons of the rate of death from all possible causes, not solely the cancer-specific death.
Data from CTCA are not available for a statistical comparison on cancer cause-specific death rates. A biopsy needle is inserted through the chest wall and into the area of abnormal lung tissue. A small piece of tissue is removed through the needle and checked under the microscope for signs of cancer.



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