Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:\r\n* Major criteria\r\n** Forced expiratory volume in 1 second (FEV1) =< 50% predicted\r\n** DLCO =< 50% predicted\r\n* Minor criteria\r\n** FEV1 51-60% predicted\r\n** DLCO 51-60% predicted\r\n** Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization\r\n** Poor left ventricular function (defined as an ejection fraction of 40% or less)\r\n** Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%\r\n** Partial pressure of carbon dioxide (pCO2) > 45 mm Hg\r\n** Modified medical research council (MMRC) dyspnea scale >= 3\r\n** Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons
DLCO/VA and FEV1 ? 50% of predicted on PFTs.
Pulmonary function (FVC, FEV1 and corrected DLCO) > 50% predicted.
Subjects must have adequate lung function to permit surgical resection determined by pre-enrollment pulmonary function tests to include diffusion capacity of the lung for carbon monoxide (DLCO) as follows:\r\n* DLCO >= 70% predicted OR DLCO < 70% but >= 55% with an oxygen consumption (VO2) max >= 10 L/min/kg (assessed by cardiopulmonary exercise testing) or 6 minute walk test >= 500 meters\r\n* Subjects with a DLCO < 55% are excluded from this study\r\n* Subjects must have a baseline oxygen (O2) saturation by pulse oximetry that is >= 92% both at rest and while walking, off supplemental oxygen
Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) ? 50% predicted (corrected for hemoglobin)
DLCO corrected < 50%; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the O2 saturation is < 92% on room air; patients with a DLCO 50-60% must also have a partial pressure of oxygen (pO2) of > 80 mmHg
Adequate pulmonary function, defined as ? grade 1 dyspnea and SaO2 ? 92% on room air; if PFTs are performed based on the clinical judgment of the treating physician, patients with FEV1 ? 50% of predicted and DLCO (corrected) of ? 40% of predicted will be eligible
GROUP 2:\r\n* Progressive pulmonary disease as defined by a decrease in the FVC or DLCO-adjusted by 10 or 15 percent or greater, respectively, from a prior FVC or DLCO-adjusted in the previous 18-month period\r\n* Patients will have diffuse cutaneous disease and may have both FVC and DLCOcorr >= 70% at screening for the study\r\n* Patients must also have evidence of alveolitis as defined by abnormal chest computed tomography (CT) or bronchoalveolar lavage (BAL)
Pulmonary dysfunction defined as:\r\n* Severe pulmonary dysfunction with (1) a hemoglobin corrected DLCO < 40% of predicted at the Baseline Screening visit, or (3) FVC < 45% of predicted Baseline Screening visit, or\r\n* Partial pressure (pO2) < 70 mmHg or pCO2 >= 45 mmHg without supplemental oxygen, or \r\n* O2 saturation < 92% at rest without supplemental oxygen as measured by forehead pulse oximeter
DLCO =< 60%
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with an FEV1 of =< 65% or DLCO (corrected) < 40% will be excluded
EXCLUSION CRITERIA FOR TNBC: Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with an FEV1 of =< 65% or DLCO (corrected) < 40% will be excluded
FEV1 < 30% (based on absolute percent predicted using United States of America [USA]-ITS-NIH equation) on pulmonary function testing
RANDOMIZED PHASE II (ARMS K AND L): Patients must have FEV1/FVC > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
DLCO ? 40% predicted with no symptomatic pulmonary disease. If DLCO is ?35% and < 40% and the patient is asymptomatic, a pulmonary consult is required
FEV1 and corrected DLCO of 35% or > of predicted.
DLCO > 50%
Pulmonary function tests (PFT)s > 50% of predicted
Severely impaired lung function as defined as spirometry and DLCO (corrected for Hgb)\n             that is <50% of the normal predicted value and/or O2 saturation <88% at rest on room\n             air.
Poor pulmonary function: \r\n* For patients receiving a TBI based preparative regimen: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin [Hgb]) =< 60% by pulmonary function tests (PFTs)\r\n* For patients receiving a non-TBI based preparative regimen: FEV1, FVC, and DLCO =< 50% predicted (corrected for hemoglobin) for patients who have not received thoracic or mantle irradiation\r\n* For patients who have received thoracic or mantle irradiation, FEV1 and FVC < 70% predicted or DLCO =< 50 of predicted; for children unable to perform PFTs because of developmental stage pulse oximetry =< 92% on room air (RA): no evidence of dyspnea at rest, no exercise intolerance\r\n* For children who are unable to cooperate for PFTs, required criteria are: no evidence of dyspnea at rest, no exercise intolerance, and not requiring supplemental oxygen therapy
Diffusion lung capacity for carbon monoxide (DLCO) adjusted for hemoglobin >= 60% predicted, except if related to high volume metastatic GCT to the lungs, in which case there is no minimum DLCO requirement; in some cases, patients may not be able to undergo pulmonary function test (PFT) testing due to the severity of their presentation, such as those with high volume lung metastases or tumor-related pain (from large mediastinal masses, pleural disease, etc.) limiting their ability to complete PFTs; even when PFTs can be completed in these cases, patients will still be eligible if the low DLCO can be attributed directly to the patient's disease (e.g. large mediastinal mass) rather than intrinsic lung disease; since there is no minimum DLCO for these patients, under these extraordinary circumstances, this will be allowed; most patients in this situation will be expected to receive disease-stabilizing chemotherapy; an unadjusted DLCO may be used in place of the DLCO adjusted for hemoglobin in certain situations as per institutional policy; for example, MSKCC policy is to not adjust the DLCO for hemoglobin when the hemoglobin is >= 14.6 g/dL for males and >= 13.4 g/dL for females; in these cases, the unadjusted DLCO must be >= 60% predicted
DLCO > 50 percent predicted
Inadequate pulmonary function with mechanical parameters < 40% predicted (FEV1, FVC, TLC, DLCO).
Patients must be considered a candidate for surgical resection of the primary tumor; standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of non-small cell lung cancer (NSCLC) may include any of the following: baseline forced expiratory volume in 1 second (FEV1) > 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease
FEV1 < 65% predicted, FVC < 65% of predicted, DLCO (corrected for hemoglobin [Hgb]) < 50% predicted); pulmonary function tests (PFTs) within 4 months prior to consent for Step I will be required for patients with underlying risk factors such as smoking history > 10 pack years, or a history of pre-existing symptomatic lung disease (not including melanoma metastases to the lung)
Clinically significant pulmonary dysfunction (FEV1< 65% predicted or FVC < 65% of predicted, DLCO (corrected for Hgb) < 50% predicted)
Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, [PCR]); however, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-operative (op) recovery period, or removal of adjacent functioning lung) or refuse surgery; deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline forced expiratory volume in one second (FEV1) < 40% predicted; post-operative predicted FEV1 < 30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption < 50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease; any of these problems will qualify a patient for this trial
Diagnosis of SSc as defined by American College of Rheumatology and at high-risk for fatal outcome based on the following prognostic factors; patients must have (1) both a and b below and (2) at least one of c, d, e, or f\r\n* a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows or knees and/or torso, in addition to distal extremity involvement\r\n* b) Duration of systemic sclerosis =< 5 years from the onset of first non-Raynaud’s symptom\r\n* c) Presence of interstitial or pulmonary vascular lung involvement (forced vital capacity [FVC] or DLCO < 70% of predicted) especially with evidence of alveolitis (abnormal bronchoalveolar lavage or high-resolution chest CT scan)\r\n* d) Presence of SSc-related pulmonary disease and alveolitis (abnormal bronchoalveolar lavage or high-resolution chest CT scan) with FVC or DLCO between 70% and 80% predicted, AND a drop in FVC > 15% predicted within the preceding 18 months\r\n* e) Presence of myocardial disease (arrhythmia needing therapy, cardiomegaly, presence of moderate or large pericardial effusion, or left axis deviation on electrocardiogram [EKG])\r\n* f) History of SSc renal crisis
Severe pulmonary dysfunction with a hemoglobin corrected DLCO < 30% or FVC < 40% of predicted or O2 saturation < 92% at rest without supplemental oxygen
FEV1, FVC and corrected DLCO > 40%.
Recipient must have adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an FEV1 >50% (predicted) and a DLCO >40% (predicted), corrected for hemoglobin.
Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:\r\n* Major criteria\r\n** Predicted postoperative forced expiratory volume in one second (FEV1) =< 40%\r\n** Predicted postoperative DLCO =< 40%\r\n** Age >= 72\r\n* Minor criteria\r\n** Predicted postoperative FEV1 41-60%\r\n** Predicted postoperative DLCO 41-60%\r\n** Pulmonary hypertension (defined by a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization\r\n** Poor left ventricular function (defined as an ejection fraction 40% or less)\r\n** Resting or exercising arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%\r\n** Partial pressure of carbon monoxide (pCO2) > 45 mm Hg\r\n** Modified Medical Research Council Dyspnea Scale >= 3
Documented pulmonary disease with DLCO ?65% or FEV1 ?65%, provided that patients do not require more than 2 L of oxygen per minute or,
Sorror’s co-morbidity factors with total score >= 4\r\n* Important modification to co-morbidity index calculation: DLCO adjusted will not be included in assessment of pulmonary risk, except those patients with DLCO adjusted < 50% who are excluded from the trial
Corrected DLCO > 40% by pulmonary function test
Subjects with adequate physical function as measured by:a)Cardiac: Left ventricular ejection fraction at rest must be >35%, or shortening fraction > 25%. b)Hepatic: Bilirubin < 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase < 5 x ULN. c)Renal: Serum creatinine within normal range for age, or creatinine clearance or GFR > 40 mL/min/1.73m2. d)Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); or 02 saturation > 92% on room air.