Survival of Patients with Stage I Lung Cancer Detected on CT Screening (NEJM, October 26, 2006) November 12, 2006
Posted by rajkmd in Oncology, Primary Care, Pulmonary/Critical Care.11 comments
For the actual article, click here
Background
- In 1993, the International Early Lung Cancer Action Project (I-ELCAP) studied the use of CT cancer as a screening tool in the early detection of lung cancer .
- The study found that eighty percent of lung cancers detected by annual screening were stage 1 cancer.
- But does this actually save lives?
- Using ELCAP protocal, this study investigates whether early detection leads to a mortality benefit.
- This study was supported with grants from National Institute of Health
Methods
- For a flowchart of the actual protocol, click here
- Pt’s initially underwent baseline screening. If the patient had a negative CT scan, then they underwent annual screening at 12 month intervals
- This is a prospective, observational trial with no control group.
- For baseline screening, a positive result on the initial low-dose CT scan was defined as
- At least one solid (completely obscuring lung paranchyma) or partly solid (obscuring part of paranchyma) non calcified pulmonary nodule 5 mm or more in diameter
- At least one non solid, non calcified pulmonary nodule 8mm or more in diameter, or
- a solid endobronchial nodule
- For positive results at the baseline screen:
- Patients with nodules 5 mm to 14 mm were either re-imaged with CT scan or underwent a PET scan. If the PET scan was positive or after 3 months the CT scan showed nodules that were growing, then a biopsy was performed
- For lesions greater or equal to 15 mm, biopsy was immediately performed.
- Lesions that were suspected to be infections underwent a 2wk period of antibiotics
- For annual screening, a positive results was any newly identified noncalcified nodule, regardless of size.
- Repeat CT scan performed for nodules less than 5 cm at 3 months or 6 months depending on the size of the nodule. If there was no growth in the nodules, then the workup was stopped and pt was re-screened at 12 month interval from the previous CT
- For pts with nodules greater than 5 cm, a 2wk course of antibiotics was prescribed followed by a CT scan one month later. If the nodules did not resolve, then a biopsy was performed
- Patients were enrolled from 1993 to 2995
- Inclusion criteria- 40 yo or older, at risk for lung cancer b/c of cigarette smoking, occupational exposure, or exposure to second hand smoking, pts were “considered fit” to undergo thoracic surgery
- 31,567 pts underwent baseline screening and of these, 27,456 underwent annual screening
- The average age 61 yo and median pack year history was 30
Results
- Among the 31,567 asymptomatic patients that underwent baseline screening, 405 patients were diagnosed with lung cancer.
- Among the 27,456 patients who underwent annual screening 74 patients were diagnosed with lung cancer.
- Of the total of 484 patients that developed lung cancer, 411 (85 percent) underwent resection, 57 (12 percent) underwent radiation and/or chemotherapy, and 16 recieved no treatment.
- Of the 484 patients diagnosed 85% had stage I lung ca
- The estimated 10 year survival for all participants was 80% (95%CI, 74 to 85), but in patients with stage I disease the survival rate was 88% (95% CI, 84 to 91). Moreover, in patients with stage 1 disease who underwent resection within 0ne month of diagnosis the survival rate was 92 % (95% CI, 88 to 95).
- The operative mortality rate was 0.5%.
Discussion
- The authors contend that using CT scans to screen for lung cancer could prevent 80% of death from lung cancer. Currently the death rate of lung cancer in US is 95%.
- The rate of detection in this study was 1.3% on baseline screen and 0.3% on annual screen, which is comparable to breast cancer screening with mammograms.
THE BOTTOM LINE: In high risk patients patients, using the I-ELCAP protocol which includes a baseline CT scan and subsequent annual CT scans, 85 percent of the cancers identified in this study were stage I disease. Moreover, the ten year survival was 80 percent in all patients diagnosed with lung cancer, 88 percent in patients with stage I disease, and 92% in patients with stage I disease and resection within one month of diagnosis.
Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. (Diabetes Care, Aug. 2006) November 6, 2006
Posted by healthweb in Endocrine, Primary Care.5 comments
by Dr. David Weir
This is a summary of the recently published consensus statement on management of type 2 diabetes by the ADA and the European Association for the Study of Diabetes. This statement includes an algorithm for the initiation of medications in diabetic patients. Both the DCCT and the UKPDS studies have shown that improved glycemic control can reduce the complications associated with diabetes. In both type 1 and type 2 diabetes retinopathy, nephropathy, and neuropathy complications are reduced with lower A1C levels.
Goals of therapy:
1. In general an A1C of <7%, but as close to normal (<6%) as
possible without hypoglycemia.
2. If a patients A1C is >7% it’s time to initiate or change therapy.
3. Early intervention: initiating therapy at lower glycemic levels are
associated with lower A1C levels in the long run.
Therapy:
1. Lifestyle interventions:
a. Weight loss and exercise. Expected decrease in A1C of 1-2%.
Although lifestyle changes are difficult for patients to sustain with a high rate of relapse it should be encouraged at every office visit. Weight loss and exercise also improve other risk factors for diabetics, namely blood pressure and lipid profile. Lifestyle changes are cheap and have a favorable side-effects profile. Patients will have improved hyperglycemia with a weight loss of as little as 8 pounds.
2. Medications:
a. Metformin: first line agent, inexpensive. Expected decrease in A1C 1.5
b. Insulin: inexpensive, improved lipid profile. Expected decrease in A1C 1.5-2.5
c. Sulfonylureas: inexpensive. Expected decrease in A1C 1.5
d. TZDs: improved lipid profile. Expected decrease in A1C 0.5-1.4
Other drugs:
e. Alpha-Glucosidase inhibitors: Expected decrease in A1C 0.5-0.8
f. Exenatide (Byetta): weight loss. Expected decrease in A1C 0.5-1
g. Glinides: short duration. Expected decrease in A1C 1-1.5
h. Pramlintide: weight loss. Expected decrease in A1C 0.5-1
Treatment algorithm:
Step 1: Lifestyle interventions and metformin.
-Metformin should be titrated to maximally effective dose (usually
850mg bid) over 1-2 months.
-Consider adding additional medications with persistent symptomatic hyperglycemia.
-Check A1C every 3 months until <7%, then every 6 months.
Step 2: If A1C >7%, add second agent.
-Insulin. Most effective at lowering A1C. First choice for patients with A1C >8.5 or symptomatic hyperglycemia.
-Sulfonylurea. Least expensive oral agent.
-TZD. No hypoglycemia.
Step 3: If A1C > 7%, start or intensify insulin therapy.
-Adding or intensifying insulin is usually more effective than adding a third oral agent to reach glycemic goal.
-Intensify insulin usually with preprandial short or rapid-acting
insulin.
-With preprandial insulin secretagogues should be discontinued or
tapered.
Most patients will require more than one medication given the progressive nature of type 2 diabetes. Insulin and metformin or insulin and a TZD have greater synergy at lowering A1C than metformin and a TZD. In uncontrolled diabetics (fasting glucose >250, random glucose >300, A1C >10%, ketonuria, or symptoms) lifestyle interventions with insulin should be started first with addition of oral agents as symptoms resolve.
Goals of algorithm:
- Achieve and maintain glycemic goals.
- Initial therapy with lifestyle interventions and metformin.
- Rapid addition of medications.
- Early addition of insulin.
Dr. Nate Link on the STAR-2 trial October 24, 2006
Posted by rajkmd in Primary Care, Women's Health.1 comment so far
- This comment is in relation to the following trial:
- The STAR P-2 trial is the most recent of several studies assessing the impact of SERMS on breast cancer. In the NSABP P-1 trial (NCI 1998;90:1371), tamoxifen prevented about 4 cases of breast cancer per 1000 high risk women treated per year (a 50% relative risk reduction!) but caused modest increases in thromboembolism, stroke, and endometrial cancer. In the MORE trial (JAMA 1999;282:637) raloxifene prevented 4 breast cancers and 6 vertebral fractures per 1000 women per year but also caused increases in thromboembolism and stroke. The STAR P-2 trial was the first to compare these two drugs head to head.Based on all three trials we would expect either raloxifene or tamoxifen to reduce the incidence of invasive breast cancer by 50%, but all the prevented cancers will be estrogen receptor positive, the tumors that are the easiest to treat and cure anyway. The studies were not large enough or long enough to determine whether breast cancer mortality will be affected by the SERMS. The scorecard: for every 1000 women at high risk for breast cancer who take raloxifene for one year, one can expect treatment to prevent 4 cases of invasive breast cancer and 6 cases of vertebral fracture, and to cause 1 stroke and 2 cases of thromboembolism. Mortality is unlikely to be affected in the short-term. Tamoxifen appears to be somewhat more likely to cause thromboembolism and uterine cancer – probably about 1 case per 1000 of each – and less likely to prevent fractures. Overall, raloxifene appears to have an edge in benefits versus risks.
- Despite the favorable publicity surrounding these results, the nuances of the data and modest increases in serious outcomes such as stroke and thromboembolism preclude a simple recommendation for use of SERMS. The higher the baseline risk of breast cancer, the more favorable will be the benefit/risk ratio, but patient preference clearly needs to be a part of this decision.
