PMID- 17337086
OWN - NLM
STAT- MEDLINE
DCOM- 20070712
LR  - 20221207
IS  - 0169-5002 (Print)
IS  - 0169-5002 (Linking)
VI  - 56
IP  - 2
DP  - 2007 May
TI  - A novel triplet regimen with paclitaxel, carboplatin and gemcitabine (PACCAGE) as 
      induction chemotherapy for locally advanced unresectable non small cell lung 
      cancer (NSCLC).
PG  - 247-54
AB  - Phase II study of 3 cycles of triplet induction chemotherapy (response, toxicity) 
      followed by radiotherapy in locally advanced non small cell lung cancer (NSCLC). 
      BACKGROUND: Patients with locally advanced inoperable non-small cell lung cancer 
      are currently treated with concomitant or sequential chemotherapy and 
      radiotherapy. However, the outcome of existing treatment modalities is 
      unsatisfactory. Development of new strategies including more efficient systemic 
      chemotherapy is warranted. OBJECTIVE: To study the antitumour activity and 
      toxicity of a triplet combination of paclitaxel, carboplatin and gemcitabine as 
      induction chemotherapy before radiotherapy, in locally advanced NSCLC and to 
      evaluate time to progression and survival. METHODS: Three cycles of paclitaxel 
      (175 mg/m(2) by 3h infusion on day 1), carboplatin (AUC 5mg/(mlmin) by IV bolus 
      on day 1) and gemcitabine (1000 mg/m(2) by IV bolus on day 1 and 8) were 
      administered every 3 weeks in reasonably fit patients. Fractionated radiotherapy 
      with curative intent was initiated 4 weeks after the last chemotherapy 
      administration. Toxicity was assessed weekly during cycle 1 and on day 1 and 8 in 
      cycles 2 and 3. Response evaluation was performed at the end of cycle 3. RESULTS: 
      Forty-eight patients (20 stage IIIA and 28 stage IIIB) received a total of 134 
      cycles of chemotherapy. Forty-two patients received the intended 3 cycles. Thirty 
      patients obtained an objective response (1 complete and 29 partial response) or 
      62.5% on the intent to treat analysis (95% confidence interval: 49-76%). None of 
      the responders became eligible for surgery. The median time to progression and 
      survival for all patients was 10.1 and 15.7 month, respectively. A significant 
      difference was observed in survival parameters between stage IIIA and stage IIIB 
      patients. Haematological toxicity grade 3/4, mainly neutropenia and 
      thrombocytopenia, was most prominent on day 15 of the treatment cycles. 
      Haematological support by means of recombinant erythropoietin, red blood cell or 
      platelet transfusion, filgrastim administration or a combination was needed in 21 
      patients. None of the patients discontinued chemotherapy because of 
      haematotoxicity. Grade 3/4 non-haematological toxicity leading to chemotherapy 
      withdrawal occurred early during induction (2 and 1 in cycles 1 and 2, 
      respectively). CONCLUSION: Three cycles of the novel triplet combination of 
      paclitaxel, carboplatin and gemcitabine (PACCAGE) is an active and feasible 
      induction regimen for patients with locally advanced inoperable NSCLC. 
      Neutropenia and to a lesser extent thrombocytopenia represent the main 
      haematological toxicity. Whether this triplet regimen can improve outcome when 
      compared to specific cisplatin doublet regimens should be evaluated in a phase 
      III study.
FAU - Schallier, D
AU  - Schallier D
AD  - Department of Medical Oncology, Oncologisch Centrum, AZ-VUB, Laarbeeklaan 101, 
      1090 Brussels, Belgium.
FAU - Neyns, B
AU  - Neyns B
FAU - Fontaine, C
AU  - Fontaine C
FAU - Steene, J Vande
AU  - Steene JV
FAU - De Mey, J
AU  - De Mey J
FAU - Meysman, M
AU  - Meysman M
FAU - De Greve, J
AU  - De Greve J
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20070306
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0W860991D6 (Deoxycytidine)
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carboplatin/administration & dosage/adverse effects
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/radiotherapy
MH  - Combined Modality Therapy
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality/radiotherapy
MH  - Male
MH  - Middle Aged
MH  - Neoadjuvant Therapy
MH  - Paclitaxel/administration & dosage/adverse effects
MH  - Survival Rate
MH  - Gemcitabine
EDAT- 2007/03/06 09:00
MHDA- 2007/07/13 09:00
CRDT- 2007/03/06 09:00
PHST- 2006/07/26 00:00 [received]
PHST- 2006/11/15 00:00 [revised]
PHST- 2006/12/18 00:00 [accepted]
PHST- 2007/03/06 09:00 [pubmed]
PHST- 2007/07/13 09:00 [medline]
PHST- 2007/03/06 09:00 [entrez]
AID - S0169-5002(06)00669-6 [pii]
AID - 10.1016/j.lungcan.2006.12.017 [doi]
PST - ppublish
SO  - Lung Cancer. 2007 May;56(2):247-54. doi: 10.1016/j.lungcan.2006.12.017. Epub 2007 
      Mar 6.