Selected abstracts from the 41st annual meeting of the
American Society of Clinical Oncology reported in this supplement to ONI
Bezjak A, Shepherd F, et al: Symptom response in non-small-cell lung cancer (NSCLC) patients (pts) treated with
erlotinib: Quality of life analysis of the NCIC CTG BR.21 trial (abstract 7018). J Clin Oncol 23(16S): 625s, 2005.
Clark GM, Zborowski D, et al: Smoking history is more predictive of survival benefit from erlotinib for patients with
non-small-cell lung cancer than EGFR expression (abstract 7033). J Clin Oncol 23(16S): 628s, 2005.
Cufer T, Vrdoljak E, on behalf of the SIGN study group: Results from a phase II, open-label, randomized study
(SIGN) comparing gefitinib with docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) nonsmall-
cell lung cancer (abstract 7035). J Clin Oncol 23(16S): 629s, 2005.
Selected abstracts from the 41st annual meeting of ASCO, continued
Davies AM, Lara PN, et al: Intermittent erlotinib in combination with docetaxel (DOC): phase I schedules designed to
achieve pharmacodynamic separation (abstract 7078). J Clin Oncol 23(16S): 639s, 2005.
Escudier B, Szczylik C, et al: Randomized phase III trial of the Raf kinase and VEGFR inhibitor sorafenib (BAY 43-9006)
in patients with advanced renal cell carcinoma (RCC) (abstract 4509). J Clin Oncol 23(16S): 380s, 2005.
Fanucchi MP, Fossella F, et al: Bortezomib ± docetaxel in previously treated patients with advanced non-small-cell
lung cancer (NSCLC): A phase II study (abstract 7034). J Clin Oncol 23(16S): 629s, 2005.
Giaccone G, Lechevalier T, et al : A phase II study of erlotinib as first-line treatment of advanced non-small-cell lung
cancer (abstract 7073). J Clin Oncol 23(16S): 638s, 2005.
Gumerlock PH, Holland WS et al: Mutational analysis of K-ras and EGFR implicates K-ras as a resistance marker
in the Southwest Oncology Group (SWOG) trial S0126 of bronchioalveolar carcinoma (BAC) patients (pts) treated with
gefitinib (abstract 7008). J Clin Oncol 23(16S): 623s, 2005.
Hainsworth JD, Sosman JA, et al: Bevacizumab, erlotinib, and imatinib in the treatment of patients (pts) with advanced renal
cell carcinoma: A Minnie Pearl Cancer Research Network phase I/II trial. (abstract 4542). J Clin Oncol 23(16S): 388s, 2005.
Heymach JV, Johnson BE, et al: A randomized, placebo-controlled phase II trial of ZD6474 plus docetaxel, in patients with
NSCLC (abstract 3023). J Clin Oncol 23(16S): 197s, 2005.
Hirsch FR, Gandara DR, et al: Increased EGFR gene copy number detected by FISH is associated with increased sensitivity
to gefitinib in patients with bronchioloalveolar carcinoma (abstract 7030). J Clin Oncol 23(16S): 628s, 2005.
Kawada I, Soejima K, et al: Quick screening of EGFR mutation using restriction fraction length polymorphism
(abstract 7071). J Clin Oncol 23(16S):638s, 2005.
Kim ES, Kies M, et al: Phase II study of combination cisplatin, docetaxel and erlotinib in patients with metastatic/
recurrent head and neck squamous cell carcinoma (HNSCC) (abstract 5546). J Clin Oncol 23(16S): 511s, 2005.
Kris MG, Sandler A, et al: EGFR and K-ras mutations in patients with bronchioloalveolar carcinoma treated with
erlotinib in a phase II multicenter trial (abstract 7029). J Clin Oncol 23(16S): 627s, 2005.
Lee DH, Han JY, et al: A phase II study of gefitinib as a first-line therapy of advanced or metastatic adenocarcinoma
of the lung in lifetime non-smokers (abstract 7072). J Clin Oncol 23(16S):638s, 2005.
Lilenbaum R, Bonomi P, et al: A phase II trial of cetuximab as therapy for recurrent non-small-cell lung cancer: Final
results (abstract 7036). J Clin Oncol 23(16S): 629s, 2005.
Miller VA, Zakowski M, et al: EGFR mutation, immunohistochemistry and chromogenic in situ hybridization as predictors
of sensitivity to erlotinib and gefitinib in patients with NSCLC (abstract 7031). J Clin Oncol 23(16S):628s, 2005.
Moore M: Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A
phase III trial of the NCI of Canada Clinical Trials Group (abstract 1). J Clin Oncol 23(16S):1s, 2005.
Pham D, Kris MG, et al: Estimation of the likelihood of epidermal growth factor receptor (EGFR) mutations based on
cigarette smoking history in patients with adenocarcinoma of the lung (abstract 7069). J Clin Oncol 23(16S): 637s, 2005.
Rini B, Rixe O, et al: AG-013736, a multi-target tyrosine kinase receptor inhibitor, demonstrates anti-tumor activity
in a Phase 2 study of cytokine-refractory, metastatic renal cell cancer (abstract 4509). J Clin Oncol 23(16S):
Sandler AB, Gray R, et al: Randomized phase II/III trial of paclitaxel (P) plus carboplatin (C) with or without
bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC):
An Eastern Cooperative Oncology Group (ECOG) Trial - E4599 (abstract LBA4). J Clin Oncol 23(16S): 2s2005.
Spigel DR, Hainsworth JD, et al: Bevacizumab and erlotinib in the treatment of patients with metastatic renal
carcinoma (RCC): Update of a phase II multicenter trial (abstract 4540). J Clin Oncol 23(16S): 387s, 2005.
Takano T, Ohe Y, et al: Evaluation of epidermal growth factor receptor (EGFR) mutations and gene copy numbers as
predictors of clinical outcomes in Japanese patients with recurrent non-small-cell lung cancer (NSCLC) receiving gefitinib
(abstract 7032). J Clin Oncol 23(16S): 628s, 2005.
Thomas MB, Dutta A, et al: A phase II open-label study of OSI-774 (NSC 718781) in unresectable hepatocellular
carcinoma (abstract 4038). J Clin Oncol 23(16S): 317s, 2005.
Tsao MS, Sakurada A, et al: Molecular analysis of the epidermal growth factor receptor (EGFR) gene and protein
expression in patients treated with erlotinib in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
trial BR.2.1 (abstract 7007). J Clin Oncol 23(16S): 622s, 2005.
Oncology NEWS International.
Korean study yields ‘very impressive’ results
Gefitinib Shows Promise in Never Smokers With Advanced Lung Adenocarcinoma
September 1, 2005
GOYANG, Korea-Singleagent gefitinib(Drug information on gefitinib) (Iressa) appears to be a
very promising treatment in Korean
patients who have never smoked and
have advanced or metastatic adenocarcinoma
of the lung, according to
the findings of a phase II trial that
tested the targeted drug as first-line
therapy. The results of the trial warrant
further study of gefitinib in this
population, said Dae Ho Lee, MD,
who led the trial at the National Cancer
Center in Goyang, Gyeonggi, Republic
of Korea (abstract 7072).
Drug of Choice
The discussant of this abstract, Roman
Perez-Soler MD, chief of the oncology
division at the Montefiore Medical
Center, New York, called the results
"very impressive," adding that he is
"convinced that gefitinib was definitely
the drug of choice for this patient population."
The trial enrolled 55 patients, 51 of
them women. All had previously untreated
stage IIIb or IV adenocarcinoma
and no smoking history. Twenty of
the patients had evaluable brain metastases.
Treatment consisted of gefitinib
at 250 mg daily for 28 days until
disease progression or unacceptable
toxicity. Objective tumor responseswere assessed every two cycles.
Overall, 61.1% of the patients had a
response to the drug; partial responses
were seen in 57.4% of patients and
complete responses in 3.7% (Table 1).
About 11.1% had stable disease. Of
the 20 patients with brain metastases,
12 had responses in both intracranial
and extracranial lesions, and one patient
who had a "dramatic response"
in extracranial lesions showed only
stable disease in intracranial lesions,
Dr. Lee said. Analysis of the responsesfound no correlation with sex, performance
status, or bronchioalveolar features.
The drug showed a good toxicity
profile, with no significant hematologic
adverse effects. Serious toxicities
included a grade 3 rash in two patients;
a grade 3 elevated liver enzyme
in three patients; and grade 3 asthenia,
vomiting, and neuropathy, each in one
Assessing EGFR Status
In his discussion, Dr. Perez-Soler
said that one remaining question is
related to patient selection: Would
knowing the mutational status of the
patients' epidermal growth factor receptors
(EGFRs) or numbers of EGFR
gene copies help in selecting patients
who would benefit from gefitinib? "I
understand that these analyses will be
done," he said, "and it will be nice to
see whether [improved patient selection]
can actually increase the survival
To follow up on this trial, the researchers
have initiated a phase III
study of gefitinib vs standard chemotherapy- gemcitabine(Drug information on gemcitabine) (Gemzar) and cisplatin(Drug information on cisplatin)-in this population. That trial
will include correlative studies of
EGFR mutations, Dr. Lee said.
Selected Reports From ASCO 2005
Novel Molecular Therapies for Advanced
Lung Cancer and Other Solid Tumors