- NA references
Crizotinib versus Chemotherapy in Advanced ALK-Positive Lung Cancer
Investigated (inv)
Comparator (comp)
Time to response
6.3 mo
12.6 mo
(all grades, %)
CRIZ
chemo
p
Upper respiratory infection
26
13
NA
- histologically or cytologically proven diagnosis of non-small cell lung cancer
- positive for the ALK fusion gene (test provided by a central laboratory)
- must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
- tumors must be measurable
- prior treatment with crizotinib (PF-02341066)
- current treatment in another clinical trial
Characteristics
CRIZ
chemo
Agedc-comma sex
Median age (range) yr
51 (22-81)
49 (24-85)
Male - no.(%)
75 (43)
78 (45)
Race - no.(%)
Smoking status - no.(%)
Tumor histologic type - no.(%)
Adenocarcinoma
164 (95)
164 (94)
Non-adenocarcinoma
5 (3)
7 (4)
ECOG performance status - no.(%)
Extent of disease - no.(%)
Locally advanced
7 (4)
16 (9)
Metastatic
165 (95)
158 (91)
Brain metastases - no.(%)
Presence of brain metastases
60 (35)
60 (34)
—
—
—
—
—
—
—
Ad-hoc:
no.pts inv.
no.pts comp.
CRIZ
chemo
analisys of PFS
CRIZ
chemo
HR (95% CI)
Age (n)
<65 yr (297)
—
—
0.49 (0.37-0.65)
≥65 yr (50)
—
—
0.54 (0.27-1.08)
Race (n)
Non-Asian (190)
—
—
0.45 (0.30-0.66)
Asian (157)
—
—
0.53 (0.36-0.76)
Smoking status (n)
Non-smoker (219)
—
—
0.45 (0.32-0.63)
Smoker or ex-smoker (127)
—
—
0.53 (0.34-0.83)
Tumor histologic type (n)
Adenocarcinoma (328)
—
—
0.50 (0.38-0.66)
Non-adenocarcinoma (12)
—
—
0.12 (0.01-1.02)
ECOG (n)
0 or 1 (313)
—
—
0.48 (0.36-0.63)
2 (34)
—
—
0.31 (0.12-0.86)
Brain metastases (n)
Present (120)
—
—
0.67 (0.44-1.03)
Absent (227)
—
—
0.43 (0.30-0.60)
Prior EGFR TKI therapy (n)
Yes (41)
—
—
0.48 (0.22-1.03)
No (306)
—
—
0.49 (0.37-0.66)
—
—
—
analisys of —
CRIZ
chemo
HR (95% CI)
—
—
—
—
—
—
—
—
—
—
- NA references
2016-11-10
A.M.M. Eggermont
Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy
Investigated (inv)
Comparator (comp)
(all grades, %)
IPIL
PLB
p
Discontinued treatment due to AE
53.3%
4.6%
NA
Any immune-related AE
90.4
39.7
NA
Any dermatologic AE
63.3
20.9
NA
Any gastrointestinal event
46.1
17.9
NA
Any endocrine-system event
37.8
8.0
NA
Any hepatic event
24.4
4.2
NA
Any neurologic event
4.5
1.9
NA
- Age ≥18 years
- Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
- Disease-free
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Randomization within 12 weeks of surgery.
- Prior therapy for melanoma except surgery
- Auto-immune disease.
Agedc-comma sex
Median age (range)dc-comma yr
51 (20–84)
52 (18–78)
<50 yr
214 (45.1)
211 (44.3)
51 to <65 yr
180 (37.9)
178 (37.4)
Male - no.(%)
296 (62.3)
293 (61.6)
Disease stage (AJCC 2002) - no.(%)
IIIB
213 (44.8)
207 (43.5)
IIIC with 1–3 positive lymph nodes
69 (14.5)
83 (17.4)
IIIC with ≥4 positive lymph nodes
95 (20.0)
98 (20.6)
Type of lymph-node involvement - no.(%)
Microscopic
210 (44.2)
193 (40.5)
Macroscopic
265 (55.8)
283 (59.5)
No. of positive lymph nodes on pathological testing - no.(%)
2 or 3
163 (34.3)
158 (33.2)
Ulceration - no.(%)
Yes
197 (41.5)
203 (42.6)
Unknown
21 (4.4)
29 (6.1)
—
—
—
—
—
—
—
—
—
Ad-hoc:
no.pts inv.
no.pts comp.
IPIL
PLB
analisys of RFS @5yr
IPIL
PLB
HR (95% CI)
Disease stage
IIIA
—
—
0.98 (0.46–2.09)
IIIB
—
—
0.75 (0.50–1.14)
Disease stage
IIIC with 1–3 positive lymph nodes
—
—
1.00 (0.56–1.80)
IIIC with ≥4 positive lymph nodes
—
—
0.48 (0.28–0.81)
No. of positive lymph nodes
2 or 3
—
—
0.83 (0.53–1.30)
Type of positive lymph node
Microscopic
—
—
0.61 (0.39–0.96)
Macroscopic
—
—
0.80 (0.58–1.11)
Ulceration
Lymph-node and ulceration status
Microscopic and ulceration
—
—
0.54 (0.29–0.99)
Macroscopic and ulceration
—
—
0.76 (0.46–1.23)
Lymph-node and ulceration status
Microscopic and no ulceration
—
—
0.62 (0.30–1.29)
Macroscopic and no ulceration
—
—
0.90 (0.56–1.45)
No. of positive lymph nodes
—
—
analisys of OS @5yr
IPIL
PLB
HR (95% CI)
Disease stage
IIIA
—
—
0.98 (0.46-2.09)
IIIB
—
—
0.75 (0.50-1.14)
Disease stage
IIIC with 1–3 positive lymph nodes
—
—
1.00 (0.56-1.80)
IIIC with ≥4 positive lymph nodes
—
—
0.48 (0.28-0.81)
No. of positive lymph nodes
2 or 3
—
—
0.83 (0.53-1.30)
Type of positive lymph node
Microscopic
—
—
0.61 (0.39-0.96)
Macroscopic
—
—
0.80 (0.58-1.11)
Ulceration
Lymph-node and ulceration status
Microscopic and ulceration
—
—
0.54 (0.29-0.99)
Macroscopic and ulceration
—
—
0.76 (0.46-1.23)
Lymph-node and ulceration status
Microscopic and no ulceration
—
—
0.62 (0.30-1.29)
Macroscopic and no ulceration
—
—
0.90 (0.56-1.45)
No. of positive lymph nodes
—
—
- NA references
2012-02-23
Jeffrey A. Sosman
Survival in BRAF V600–Mutant Advanced Melanoma Treated with Vemurafenib
Investigated (inv)
Comparator (comp)
(all grades, %)
VEMR
NA
p
Photosensitivity reaction
52
—
NA
Cutaneous squamous-cell carcinomaor keratoacanthoma
26
—
NA
Elevated liver enzymes
17
—
NA
Peripheral neuropathy
10
—
NA
- adult patients >/=18 years of age
- histologically confirmed metastatic melanoma (Stage IV, AJCC)
- patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
- BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
- measurable disease by RECIST criteria
- negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion.
- active CNS metastases on CT/MRI within 28 days prior to enrollment
- history of or known carcinomatous meningitis
- previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
- cardiac dysrhythmias >2 NCI CTCAE or treatment with drugs with dysrhythmic potential
- uncontrolled hypertension(>150/100mmHg) despite optimal medical therapy
- infectious disease including HIV, HBV and HCV.
Agedc-comma sex
Race or ethnic group - no.(%)
No. of prior therapies - no.(%)
Previous interleukin-2 - no.(%)
Previous ipilimumab - no.(%)
ECOG status score - no.(%)
Metastatic stage at diagnosis - no.(%)
Serum LDH - no.(%)
BRAF mutation
—
—
—
—
—
Ad-hoc:
no.pts inv.
no.pts comp.
VEMR
NA
analisys of ORR @12,9mo.
VEMR
NA
HR (95% CI)
Age
LDH at enrolment
ECOG
Metastatic stage
No. of prior therapies
Previous IL-2
Sex
—
—
—
analisys of —
VEMR
NA
HR (95% CI)
—
—
—
—
—
—
—
—
—
—