Trial Outcomes & Findings for S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer (NCT NCT00445848)

Last Updated: 2020-03-05

Results Overview

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

Results posted on

2020-03-05

Participant Flow

89 patients were enrolled. Four patients were excluded from the analysis: two patients were ineligible due to incorrect histology; two were no analyzable due to their not receiving any treatment on protocol.

Participant milestones

Participant milestones
Measure	Erlotinib and Bevacizumab Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Overall Study STARTED	85
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	85

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib and Bevacizumab Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Overall Study Adverse Event	14
Overall Study Withdrawal by Subject	4
Overall Study Progression	62
Overall Study Other-Not protocol specified	5

Baseline Characteristics

S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib and Bevacizumab n=85 Participants Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Age, Continuous	61 years n=99 Participants
Sex: Female, Male Female	56 Participants n=99 Participants
Sex: Female, Male Male	29 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	56 participants n=99 Participants
Race/Ethnicity, Customized African American	4 participants n=99 Participants
Race/Ethnicity, Customized Asian	21 participants n=99 Participants
Race/Ethnicity, Customized Native American	2 participants n=99 Participants
Race/Ethnicity, Customized Unknown	2 participants n=99 Participants
Performance Status 0/1	82 participants n=99 Participants
Performance Status 2	3 participants n=99 Participants
Stage IIIB(pleural effusion)	15 participants n=99 Participants
Stage IV	70 participants n=99 Participants

PRIMARY outcome

Timeframe: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Erlotinib and Bevacizumab n=85 Participants Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Overall Survival	29.8 months Interval 22.5 to 37.8

SECONDARY outcome

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration.

Outcome measures

Outcome measures
Measure	Erlotinib and Bevacizumab n=85 Participants Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Progression-free Survival	7.4 months Interval 6.1 to 10.9

SECONDARY outcome

Population: Only patients with measurable disease at baseline were included in the analysis. 66 of 85 patients (78%) had measurable disease at baseline.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.

Outcome measures

Outcome measures
Measure	Erlotinib and Bevacizumab n=66 Participants Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Response Rate (Complete and Partial) Complete Response (CR)	2 participants
Response Rate (Complete and Partial) Partial Response (PR)	31 participants
Response Rate (Complete and Partial) Objective Response Rate (CR + PR)	33 participants
Response Rate (Complete and Partial) Stable Disease (SD)	23 participants
Response Rate (Complete and Partial) Non-Progression (ORR+SD)	56 participants
Response Rate (Complete and Partial) Progressive Disease (PD)	8 participants
Response Rate (Complete and Partial) Not Determinable/ Inadequate Assessment	2 participants

SECONDARY outcome

Timeframe: Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.

Population: Eligible patients who had received the protocol treatments were included in the adverse event summaries.

Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Outcome measures

Outcome measures
Measure	Erlotinib and Bevacizumab n=85 Participants Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs ALT, SGPT (serum glutamic pyruvic transaminase)	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs AST, SGOT	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bilirubin (hyperbilirubinemia)	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Calcium, serum-low (hypocalcemia)	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Colitis, infectious (e.g., Clostridium difficile)	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Confusion	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dermatology/Skin-Other (Specify)	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Esophagitis	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue (asthenia, lethargy, malaise)	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemoglobin	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Stomach	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, pulmonary/upper respiratory - Lung	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, pulmonary/upper respiratory - Nose	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypertension	15 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis/stomatitis (clinical exam) - Oral cavity	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis/stomatitis (functional/symp) - Oral cav	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nail changes	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neuropathy: motor	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Abdomen NOS	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Bone	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Face	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Joint	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Potassium, serum-low (hypokalemia)	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Proteinuria	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pruritus/itching	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash/desquamation	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash: acne/acneiform	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sodium, serum-low (hyponatremia)	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Syncope (fainting)	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ulceration	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Voice changes/dysarthria	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Weight loss	3 Participants

Adverse Events

Erlotinib and Bevacizumab

Serious events: 17 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib and Bevacizumab n=85 participants at risk Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Blood and lymphatic system disorders Hemoglobin	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Diarrhea	3.5% 3/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Hemorrhage, GI - Stomach	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Nausea	2.4% 2/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Pancreatitis	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Vomiting	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Death not associated with CTCAE term - Death NOS	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Extremity-lower (gait/walking)	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Fatigue (asthenia, lethargy, malaise)	2.4% 2/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Pain-Other	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lung	3.5% 3/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - UTI	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Infection with unknown ANC - Lung (pneumonia)	3.5% 3/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Infection-Other	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations INR (of prothrombin time)	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Anorexia	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Dehydration	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	3.5% 3/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Neuropathy: motor	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Syncope (fainting)	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Psychiatric disorders Confusion	2.4% 2/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	3.5% 3/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Lung	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Rash/desquamation	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Vascular disorders Hypertension	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Vascular disorders Hypotension	1.2% 1/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.

Other adverse events

Other adverse events
Measure	Erlotinib and Bevacizumab n=85 participants at risk Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
Blood and lymphatic system disorders Hemoglobin	22.4% 19/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Eye disorders Dry eye syndrome	10.6% 9/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Eye disorders Ocular/Visual-Other	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Eye disorders Watery eye (epiphora, tearing)	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Constipation	15.3% 13/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Diarrhea	72.9% 62/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	16.5% 14/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Flatulence	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Heartburn/dyspepsia	15.3% 13/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Hemorrhage, GI - Oral cavity	8.2% 7/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Hemorrhage, GI - Rectum	9.4% 8/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Hemorrhoids	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	30.6% 26/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	21.2% 18/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Nausea	49.4% 42/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Pain - Abdomen NOS	22.4% 19/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Gastrointestinal disorders Vomiting	23.5% 20/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Edema: limb	16.5% 14/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Fatigue (asthenia, lethargy, malaise)	64.7% 55/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	8.2% 7/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Pain - Chest/thorax NOS	14.1% 12/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Pain-Other	14.1% 12/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
General disorders Rigors/chills	10.6% 9/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - UTI	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	9.4% 8/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Infections and infestations Infection-Other	10.6% 9/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	29.4% 25/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations AST, SGOT	34.1% 29/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Alkaline phosphatase	17.6% 15/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Bilirubin (hyperbilirubinemia)	20.0% 17/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Creatinine	23.5% 20/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Leukocytes (total WBC)	12.9% 11/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Lymphopenia	12.9% 11/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Metabolic/Laboratory-Other	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Investigations Weight loss	32.9% 28/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	21.2% 18/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Anorexia	30.6% 26/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	9.4% 8/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Dehydration	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	28.2% 24/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	11.8% 10/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	18.8% 16/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue-Other	8.2% 7/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Back	20.0% 17/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Bone	11.8% 10/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Chest wall	12.9% 11/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	16.5% 14/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Joint	28.2% 24/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Muscle	23.5% 20/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Musculoskeletal and connective tissue disorders Pain - Neck	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Dizziness	18.8% 16/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Neuropathy: sensory	17.6% 15/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Ocular/Visual-Other	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Pain - Head/headache	35.3% 30/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Nervous system disorders Taste alteration (dysgeusia)	28.2% 24/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Psychiatric disorders Insomnia	21.2% 18/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Psychiatric disorders Mood alteration - anxiety	10.6% 9/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Psychiatric disorders Mood alteration - depression	10.6% 9/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Renal and urinary disorders Glomerular filtration rate	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Renal and urinary disorders Proteinuria	24.7% 21/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Renal and urinary disorders Urinary frequency/urgency	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.1% 12/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Cough	51.8% 44/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	34.1% 29/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	41.2% 35/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	7.1% 6/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	30.6% 26/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other	14.1% 12/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Dry skin	31.8% 27/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	30.6% 26/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Nail changes	14.1% 12/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Pruritus/itching	27.1% 23/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Rash/desquamation	50.6% 43/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	74.1% 63/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Vascular disorders Hemorrhage/Bleeding-Other	5.9% 5/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.
Vascular disorders Hypertension	42.4% 36/85 • Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.

Additional Information

Lung Committee Statistican

Swog Statistical Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60