Table V-ALung Cancer: Design, Enrollment and Treatment

StudyDesignTherapeutic Settingn, Enrolled (Randomized)n, Evaluatedn, Withdrawn (Lost to F/U)Treatment Regimen (Agents)
Krug et al. 2005Phase 2 RCTUntreated advanced (Stage 3b or 4) nonsmall cell without prior chemotherapy. Prior RT must have been completed 3 weeks prior to study entry6464 (Grp1:31, Grp2:34)Docetaxel+trastuzumab (Grp1) or palitaxel+trastuzamab (Grp2)
Cappuzzo et al. 2005Prospective Clinical TrialNSCLC with locally advanced or metastatic disease which progressed after chemotherapy/medical contraindications to chemotx1021011Gefitinib
Hirsch et al. 2005Prospective Clinical TrialStage IIIb or IV BAC or adeno with BAC features 1st -line CHT (101) or 2nd+-line (36)1455689Gefitinib until progression or prohibitive toxicity
Pelosi et al. 2005RET CSStage I NSCLC with no (neo)adjuvant tx and stage I–III NET, treated345 (NSCLC
207 (NET)
Same (retrospective study)0No neoadjuvant tx for NSCLC. All pts had radical surgery+mediastinal LN dissection
Saad et al. 2004RET CSUnselected patients with stage I conventional and bronchioloalveolar adenocarcinoma1001000complete surgical resection, no chemotherapy or radiotherapy
Langer et al. 2004PIIRecurrent, stage IV, or stage IIIB NSCLC, HercepTest 1+/2+/3+56533Trastuzumab, paclitaxel and carboplatin
Cappuzzo et al. 2003PRO CSStage IIIB/IV NSCLC, pretreated with 1st-line platinum-based CHT and RT63632nd+-line gefitinib
Koukourakis et al. 1999RET CSSurgically treated NSCLC216189 with survival data27Treated with surgery alone
Koukourakis et al. 2000RET CSOperable NSCLC T1,2-N0,11121120Surgery alone without RT or Chemotx
Graziano et al. 1998PIIStage IIIA lung cancer with ipsilateral mediastinal node involvement6646 had pre-study IHC staining for Her-2. 1 additional case was not accounted for20Two cycles of cisplatin-etoposide then surgical resection ten two additional cycles of cisplatin-etoposide then radiation to the thorax
Pfeiffer et al. 1996RET CSNSCLC treated surgically without adjuvant radiotx. Two pt had adjuvant cytotoxic tx186Same (RET CS)0Radical surgery (152)
Macroscopic tissue was left in 34 pts

From: Appendix C. Evidence Data Abstraction Tables

Cover of HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors
HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors.
Evidence Reports/Technology Assessments, No. 172.
Seidenfeld J, Samson DJ, Rothenberg BM, et al.

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