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Originally published as JCO Early Release 10.1200/JCO.2005.55.405 on August 8 2005 © 2005 American Society of Clinical Oncology. Combined Chemoradiotherapy Regimens of Paclitaxel and Carboplatin for Locally Advanced Non–Small-Cell Lung Cancer: A Randomized Phase II Locally Advanced Multi-Modality ProtocolFrom the University of Pittsburgh Cancer Institute, Pittsburgh, PA; The University of Texas Southwestern Medical Center, Dallas, TX; Rush Medical College, Rush University Medical Center, Chicago, IL; American College of Radiology, Reston, VA; Highlands Oncology Center, Fayetteville, AR; Dayton Community Clinical Oncology Program, Dayton, OH; Thomas Jefferson University, Philadelphia, PA Address reprint requests to Chandra P. Belani, MD, Professor of Medicine, University of Pittsburgh School of Medicine, Co-Director, Lung and Thoracic Malignancies Program, University of Pittsburgh Cancer Institute, UPMC Cancer Pavilion, 5150 Centre Ave, 5th Floor, Pittsburgh, PA 15232; e-mail: belanicp{at}upmc.edu
PURPOSE: This phase II noncomparative randomized trial was conducted to determine the optimal sequencing and integration of paclitaxel/carboplatin with standard daily thoracic radiation therapy (TRT), in patients with locally advanced unresected stage III non–small-cell lung cancer (NSCLC). Survival data were compared with historical standard sequential chemoradiotherapy data from the Radiation Therapy Oncology Group.
PATIENTS AND METHODS: Patients with unresected stages IIIA and IIIB NSCLC, with Karnofsky performance status RESULTS: With a median follow-up time of 39.6 months, median overall survival was 13.0, 12.7, and 16.3 months for arms 1, 2, and 3, respectively. During induction chemotherapy, grade 3/4 granulocytopenia occurred in 32% and 38% of patients on study arms 1 and 2, respectively. The most common locoregional grade 3/4 toxicity during and after TRT was esophagitis, which was more pronounced with the administration of concurrent chemoradiotherapy on study arms 2 and 3 (19% and 28%, respectively). CONCLUSION: Concurrent weekly paclitaxel, carboplatin, and TRT followed by consolidation seems to be associated with the best outcome, although this schedule was associated with greater toxicity.
In the United States, lung cancer continues to be the leading cause of cancer-related deaths for both men and women.1 Non–small-cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases.2 Approximately 40% of NSCLC patients present with stages IIIA and IIIB disease.3 Thoracic radiation therapy (TRT) has been the traditional treatment approach for patients with unresected stages IIIA and IIIB NSCLC. Although TRT provides effective symptom relief and contributes to locoregional tumor control, 5-year survival rates with TRT alone are disappointing.4-6 The combination of TRT with chemotherapy has demonstrated superiority over TRT alone.7-14 Radiation Therapy Oncology Group (RTOG) 88-08 compared three regimens of TRT as follows: (1) standard TRT; or (2) sequential chemotherapy and TRT; or (3) sequential chemotherapy and hyperfractionated TRT in a phase III trial. The second schedule (sequential chemotherapy and TRT) produced the best median survival of 13.2 months.9 Recently, two randomized studies that compared concurrent versus sequential chemoradiotherapy found that the concurrent approach provides superior outcome.15,16 Both randomized trials evaluated second-generation cisplatin combinations with TRT.7-16 Subsequently, newer chemotherapeutic agents, such as paclitaxel,17 have been successfully integrated with TRT in combined modality programs.3,18-19 Pilot studies that evaluated weekly regimens of paclitaxel and carboplatin with TRT for patients with locally advanced NSCLC provided encouraging safety, efficacy, and tolerability results. However, the therapeutic benefit of either induction or consolidation full-dose chemotherapy in conjunction with concurrent chemoradiotherapy is not well defined. The pattern of failure with these approaches has also not been well established from these small phase II trials.18,19 This phase II randomized three-arm study was conducted for patients with locally advanced unresected stage III NSCLC to determine the optimal schedule sequence of paclitaxel and carboplatin when administered in combination with TRT.
Patient Eligibility Histologic or cytologic determination of stage IIIA or IIIB NSCLC (including squamous cell carcinoma, adenocarcinoma, large cell anaplastic carcinoma, and poorly differentiated NSCLC) was required. Patients with T1-T3 with N2 disease if medically inoperable, T4 with any node size and extent, and those with N3 disease with any tumor involvement were eligible. Patients were required to have measurable disease; those with significant pleural effusions seen on chest x-ray were not eligible.
Additional eligibility criteria included patient age The protocol was approved by the institutional review boards with jurisdiction over each site at which patients were registered, and all patients gave written informed consent before enrollment. Two weeks before study entry, complete documentation of medical history and a physical exam of all patients was taken, which included: weight, performance status, WBCs/granulocytes, hemoglobin, platelet count, AST, ALT, alkaline phosphatase, total bilirubin, albumin, glucose, and creatinine (24 hour or calculated clearance). Pulmonary function tests and an ECG were performed on patients before study entry. Within 4 weeks of study entry, prestudy radiographic assessments, such as CT scans and bone scans, were obtained to document tumor staging for eligibility. CT scans were used consistently for all evaluations and tumor measurements during the entire study period. Women of childbearing potential had to have a negative urine or serum pregnancy test within the 7 days before study entry.
Treatment Schedules
Arm 1. Sequential chemotherapy consisted of two 3-week cycles of paclitaxel 200 mg/m2 administered over 3 hours, immediately followed by carboplatin at an area under the plasma concentration time curve (AUC) = 6 mg/mL · min as an intravenous infusion over 30 minutes. The dose of carboplatin was calculated using the Calvert formula with the creatinine clearance estimated using the Cockroft-Gault equation.20 TRT was initiated on day 42 and consisted of 1.8 Gy daily, five times per week (45.0 Gy target dose in 5 weeks to the initial field), followed by a total of 18.0 Gy fractions delivered at 2.0 Gy fractions daily to the initial tumor volume with reduced fields (total dose, 63.0 Gy in 34 fractions over 7 weeks), but including enlarged lymph nodes  2.0 cm. Arm 2. Patients on the induction/concurrent arm received the same chemotherapy as patients on arm 1. After completing two cycles of chemotherapy they were begun on TRT administered concurrently with weekly paclitaxel 45 mg/m2 via intravenous infusion over 1 hour, followed by carboplatin dose targeted to achieve an AUC = 2 mg/mL · min over 30 minutes, and TRT as the patients in arm 1. Arm 3. On the concurrent/consolidation arm, concurrent chemoradiotherapy as administered to patients in arm 2 was administered first, followed by consolidation chemotherapy. The consolidation consisted of two cycles initiated 3 to 4 weeks after completion of concurrent therapy, and the doses were the same as the induction regimens in arms 1 and 2.
Treatment Modifications During chemoradiotherapy on arms 2 and 3, the chemotherapy dose was reduced by 50% if the granulocyte count dropped from 1.0 to 1.49 x 103 granulocytes/mL and/or the platelet count dropped to 50 to 74.9 x 103 platelets/mL. If the granulocyte count fell below 1.0 x 103/mL and platelet count to less than 50 x 103/mL, the chemotherapy dose was omitted. Dose reductions for chemotherapy (induction or consolidation) were made as described for arm 1. In any of the assigned treatment arms, when a chemotherapy dose reduction was required, re-escalation of the chemotherapy dose was performed for subsequent doses during that specific course. In addition, on study arms 2 or 3, any dose reduction was not carried over to the next scheduled course unless deemed necessary by the investigator. Any patient unable to tolerate the 50% dose reduction of chemotherapy was taken off the study.
Radiotherapy
Assessment of Efficacy and Safety
Progression-free survival (defined as the time from start of treatment to death or progression) was a secondary study end point. Safety of the three regimens was evaluated by determining the frequency of severe (
Statistical Analysis Statistical analysis of overall survival compared with historical control was performed using a one-sided log-rank of Kaplan-Meier survival estimates. The duration of survival was calculated from the date of randomization until death or last known follow-up. Results were considered significant at the 5% level (P < .05). A Triangle Test was used to determine which, if any, arm(s) should be discontinued due to a low likelihood of benefit compared to a historical control.
Patient Characteristics Between February 1998 and June 2001, 276 patients were enrolled onto the study from 49 academic centers and community hospitals in the United States. As accrual to this phase II study reached the projected number of patients, an interim statistical analysis using the triangle test was applied to all three arms. Arm 2 was closed to accrual due to the low likelihood of benefit compared with historical control. Sample sizes in arms 1 and 3 were expanded to accommodate a phase III design. Subsequently, when data from the RTOG 9410 study became available and confirmed the benefit of concurrent therapy, accrual to the present study decreased and the study was permanently closed to accrual. The date of final analysis was May 25, 2004. Of the 276 patients enrolled, 19 patients were excluded from the final analysis; 18 due to ineligibility, and one patient due to not receiving study therapy. Reasons for ineligibility included stage IV disease (n = 3), M1 disease (n = 2), bone metastases (n = 2), cervical node metastases (n = 1), stage I disease (n = 1), prior chemotherapy (n = 1), no prestudy brain CT/MRI (n = 1), more than 10% weight loss (n = 1), no prestudy bilirubin (n = 1), pleural and pericardial effusion that was malignant (n = 1), prestudy creatinine clearance of 38 mL/min (n = 1), no prestudy absolute neutrophil count (n = 1), FEV1 less than 800 mL (n = 1), and no N2 status documentation (n = 1). A total of 257 eligible patients (arm 1, n = 91; arm 2, n = 74; arm 3, n = 92) were, therefore, evaluated for efficacy as measured by overall survival and safety. Patient baseline characteristics were comparable across all three treatment arms (Table 1). There was a higher percentage of men than women in each treatment arm and the majority of patients was younger than 70 years old. Approximately one third of patients in each arm had a 5% to 10% weight loss within the 3 months before diagnosis and two thirds of patients entered the study with stage IIIB disease. Mean hemoglobin levels at baseline were 13.15, 13.38, and 13.66 for arms 1, 2, and 3, respectively. Although there were no statistical differences, there were some minor imbalances between arms. The majority of patients in each arm had a baseline performance status of 80 to 100, with only 8% (arm 1), 7% (arm 2), and 2% (arm 3) of patients with a performance status of 70. When evaluated based on KPS 70 to 80 and 90 to 100, there were more patients in arm 2 with KPS 70 to 80 (31%) compared with the other arms (arm 1, 27%; arm 3, 24%). Similarly, 73% of patients enrolled onto arm 2 were men, compared with 69% of the patients on arm 1% and 67% on arm 3. Percentage of weight loss also differed between arms with a higher incidence of 5% to 10% weight loss in arm 2 (36%) compared with arm 1 (27%) and arm 3 (28%).
Treatment Administration Overall, in treatment arms 1, 2, and 3, 70%, 69%, and 74% of patients received the planned therapy of both treatment modalities, respectively. Ninety-five percent and 93% of patients in arms 1 and 2, respectively, received the planned two cycles of induction chemotherapy (Table 2). The reasons for not completing induction chemotherapy were progression (four patients), poor health (two patients), death (one patient), treatment-related complications (two patients), and patient refusal (one patient). During the concurrent chemoradiotherapy, 46% of patients in arm 2 and 70% of patients in arm 3 received seven weekly cycles of chemotherapy; 65% of patients in arm 2 and 85% patients in arm 3 completed at least six cycles. Failure to complete at least six weekly cycles of concurrent chemotherapy were attributed to progression (13 patients), poor health (three patients), death (one patient), treatment-related complications (19 patients), patient refusal (two patients), and other reasons (two patients). In arm 3, 67% of patients received the planned two cycles of consolidation chemotherapy. Reasons for not completing consolidation therapy were due to progression (four patients), poor health (five patients), death (four patients), treatment-related complications (11 patients), patient refusal (two patients), and other reasons (four patients).
The percentage of patients who received the scheduled radiotherapy dose was 76% in arm 1, 70% in arm 2%, and 81% in arm 3. The main reasons for receiving incomplete radiotherapy included death (arm 1, n = 1), disease progression (arm 1, n = 2; arm 2, n = 7), and patient refusal (arms 1 and 2, n = 3; arm 1, n = 2).
Efficacy For arms 1, 2 and 3, the survival curves were similar to those reported with the historical data (Figs 2, 3, and 4). No statistically significant difference in the median overall survival was observed when each of the three treatment arms were individually compared with the historical survival data from arm 2 of RTOG 88-08.
The disease progression rates at 1-year were 54% in arm 1, 46% in arm 2%, and 46% in arm 3. Median progression-free survival was 9.0 months for arm 1, 6.7 months for arm 2, and 8.7 months for arm 3.
Safety
Toxicities during and after radiation therapy for all arms are listed in Table 4. Grade 3 and 4 esophagitis occurred in 3% of patients in arm 1, in 19% of patients in arm 2, and in 28% of patients in arm 3. Grade 3/4 granulocytopenia occurred in 16% of patients in arm 2 and 26% of patients in arm 3. Grade 3/4 leukopenia occurred in 2% of patients in arm 1, 31% of patients in arm 2, and 51% of patients in arm 3. Incidence of grade 3/4 thrombocytopenia was 0% for arm 1, 9% in arm 2, and 12% in arm 3. Overall, lung toxicities occurred in 7% of patients in arm 1, 4% of patients in arm 2, and 16% of patients in arm 3. The greater incidence of toxicity observed in arms 2 and 3 as compared with the incidence in arm 1 (Table 4) was not unexpected because both arms included a combined chemotherapy and radiotherapy phase, whereas in arm 1, each modality was given separately.
Three treatment-related deaths were reported within 90 days of study initiation; one patient in arm 2 and two in arm 3. All three deaths were due to infection.
For patients with locally advanced unresected NSCLC, the combined modality regimen of chemotherapy and radiation is the accepted "standard of care."8,14 The RTOG 88-089 trial compared (1) standard TRT, (2) sequential chemotherapy and TRT, or (3) sequential chemotherapy and hyperfractionated TRT. The best median survival was 13.2 months in the sequential chemoradiotherapy group. However, at the time the present study was developed, 13.7 months was the available median survival for the sequential chemoradiotherapy arm of RTOG 88-08, so this median was used as the historical control. During the course of the present study, a median survival of 14.6 months was reported for the sequential chemoradiotherapy arm of the Radiation Therapy Oncology group 9410 study.15 The trial compared three regimens as follows: (1) sequential chemoradiotherapy, (2) concurrent chemoradiotherapy, or (3) concurrent chemotherapy and hyperfractionated TRT. The results of the present study reveal that all three treatment regimens can be safely administered, with median overall survival times of 13.0 months in arm 1, 12.7 months in arm 2, and 16.3 months in arm 3, comparing favorably with the 13.7 months in RTOG 88-08. Patient populations were slightly different between the present locally advanced multi-modality protocol study (LAMP) and RTOG 88-08. In contrast to the LAMP inclusion criteria, RTOG 88-08 allowed stage II, IIIA, or IIIB patients with a weight loss of less than 5%, and excluded all patients with pleural effusions. As this was a phase II randomized study, statistical comparison among treatment regimens was not performed; however, there was a trend toward a survival benefit for arm 3. Survival results are congruent with RTOG 88-08 and other phase II studies where stage III NSCLC patients were treated with concurrent weekly paclitaxel, carboplatin, and TRT followed by consolidation paclitaxel and carboplatin.3,18-19,21 Comparisons made to historical survival data from RTOG NSCLC studies using induction chemotherapy followed by radiation therapy indicated that none of the three arms in this study was different than historical controls.22 Recently, a number of the newer chemotherapy regimens have been evaluated with concomitant radiotherapy.23-24 The Cancer and Leukemia Group B (CALGB) combined cisplatin with either gemcitabine, paclitaxel, or vinorelbine, with two cycles given as induction chemotherapy followed by two additional cycles of attenuated doses of the same agents concurrently with TRT.25 All three treatment agents were deemed safe with similar outcomes, but with different toxicity patterns. An overall median survival of 17 months was reported, similar to the 16.3 months observed in the present trial with concurrent paclitaxel and carboplatin and TRT followed by consolidation chemotherapy.25 Based on the published results, the regimen of weekly carboplatin and paclitaxel given concurrently with TRT has become somewhat of a "community standard." To definitively evaluate whether induction full-dose chemotherapy before concurrent chemoradiotherapy is beneficial, the CALGB 39801 study was initiated. Unfortunately, this study failed to show a benefit for the role of induction chemotherapy before the concurrent regimen.26 This is analogous to what we have reported here in the LAMP trial. Treatment-related toxicity remains a concern when chemotherapy is combined with TRT. On the sequential, induction/concurrent, and concurrent/consolidation arms of this study, 70%, 69%, and 74% of the patients, respectively, completed the full planned treatment. The occurrence of esophagitis was more frequent on the concurrent/consolidation arm as expected. Similar observations have also been made on the concurrent arm of RTOG 9410, but the incidence of late toxicities such as stricture formation in the esophagus is not substantially increased when both modalities are administered simultaneously.15 In comparison to RTOG 88-08 arm 2 (sequential), the concurrent/consolidation arm of the LAMP study showed a greater incidence of grade 3 or 4 esophagitis (28% for LAMP v 3% for RTOG 88-08 arm 2), and this confirms what has been seen with the concurrent versus sequential regimens. Pulmonary toxicity was also greater in arm 3 in comparison with the other arms of this study. Other radiation approaches such as hyperfractionated radiation and continuous hyperfractionated accelerated radiotherapy seem to be promising.27-30 The Eastern Cooperative Oncology Group (ECOG 2597) compared induction chemotherapy with paclitaxel and carboplatin followed by thoracic radiotherapy with hyperfractionated accelerated radiotherapy and reported a higher median survival time in the hyperfractionated accelerated radiotherapy study arm (20.3 months v 13.7 months) with an acceptable toxicity profile.30 Clinical trials are ongoing to evaluate these novel schemes of radiation and advances in radiation therapy, such as three-dimensional conformal therapy and intensity modulated radiation therapy, which may allow the delivery of higher doses of radiation with concurrent chemotherapy.
Although the optimal treatment of locally advanced unresected NSCLC has yet to be defined, the LAMP study demonstrates that concurrent/consolidation treatment appears to be associated with the best outcome though this schedule was associated with greater toxicity. P values through 24 months for each arm on LAMP are as follows: arm 1, CT Therefore, although chemoradiotherapy followed by two to three cycles of consolidation chemotherapy seems to be the most efficacious regimen at the moment for the treatment of locally advanced NSCLC, the balance between efficacy and tolerability have to be carefully considered when choosing the appropriate multimodal treatment schedule. Integration of targeted agents into the treatment paradigms and development of newer chemotherapy platforms is being evaluated.
Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Dollar Amount Codes (A) < $10,000 (B) $10,000-99,999 (C)
The authors acknowledge the significant contribution of Jamie Zhang in the preparation of this manuscript.
Authors' disclosures of potential conflicts of interest are found at the end of this article. Supported by a grant from Bristol-Myers Squibb Company. Presented in part at the 10th World Conference on Lung Cancer, Vancouver, British Columbia, Canada, August 10-14, 2003; the American Society of Clinical Oncology Annual Meetings on May 12-15, 2001 (37th; San Francisco, CA), May 18-21, 2002 (38th; Orlando, FL), and May 31-June 3, 2003 (39th; Chicago, IL); and the 43rd Annual Meeting of the American Society for Therapeutic Radiology and Oncology, San Francisco, CA, November 4-8, 2001.
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7. Le Chevalier T, Arriagada R, Tarayre M, et al: Significant effect of adjuvant chemotherapy on survival in locally advanced non-small-cell lung carcinoma. J Natl Cancer Inst 84:58-59, 1992 8. Dillman RO, Seagren SL, Propert KJ, et al: A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in Stage III non-small-cell lung cancer. N Engl J Med 323:940-945, 1990[Abstract]
9. Sause WT, Scott C, Taylor S, et al: Radiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: Preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer. J Natl Cancer Inst 87:198-205, 1995
10. Sause W, Kolesar P, Taylor S IV, et al: Final results of phase III trial in regionally advanced unresectable non-small cell lung cancer: Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. Chest 117:358-364, 2000 11. Schaake-Koning C, van den Bogaert W, Dalesio O, et al: Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer. N Engl J Med 326:524-530, 1992[Abstract]
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16. Furuse K, Fukuoka M, Kawahara M, et al: Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol 17:2692-2699, 1999
17. Rowinsky EK, Donehower RC: Paclitaxel (taxol). N Engl J Med 332:1004-1014, 1995 18. Choy H, Akerley W, Safran H, et al: Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J Clin Oncol 16:3316-3322, 1998[Abstract] 19. Belani CP, Aisner J, Day R, et al: Weekly paclitaxel and carboplatin with simultaneous thoracic radiotherapy (TRT) for locally advanced non-small cell lung cancer (NSCLC). Proc Amer Soc Clin Oncol 16:448a, 1997 (abstr 1608) 20. Calvert AH, Newell DR, Gumbrell LA, et al: Carboplatin dosage: Prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748-1756, 1989[Abstract]
21. Pfister DG, Johnson DH, Azzoli CG, et al: American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: Update 2003. J Clin Oncol 22:330-353, 2004
22. Lau D, Leigh B, Gandara D, et al: Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: A California Cancer Consortium phase II trial. J Clin Oncol 19:442-447, 2001 23. Masters GA, Haraf DJ, Hoffman PC, et al: Phase I study of vinorelbine, cisplatin, and concomitant thoracic radiation in the treatment of advanced chest malignancies. Clin Oncol 16:2157-2163, 1998
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25. Vokes EE, Herndon JE II, Crawford J, et al: Randomized phase II study of cisplatin with gemcitabine or paclitaxel or vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy for stage IIIB NSCLC: Cancer and Leukemia Group B Study 9431. J Clin Oncol 20:4191-4198, 2002 26. Vokes EE, Herndon JE, Kelley MJ, et al: Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable non-small cell lung cancer (NSCLC): Initial analysis of a randomized phase III trial. Proc Amer Soc Clin Oncol 23:616, 2004 (abstr 7005) 27. Cox JD, Azarnia N, Byhardt RW, et al: A randomized phase I/II trial of hyperfractionated radiation therapy with total doses of 60.0 Gy to 79.2 Gy: Possible survival benefit with greater than or equal to 69.6 Gy in favorable patients with Radiation Therapy Oncology Group Stage III non-small-cell lung carcinoma—Report of Radiation Therapy Oncology Group 83-11. J Clin Oncol 8:1543-1555, 1990[Abstract] 28. Saunders MI, Dische S, Grosch EJ, et al: Experience with CHART. Int J Radiat Oncol Biol Phys 21:871-878, 1991[Medline] 29. Saunders MI, Dische S, Barrett A, et al: Randomised multicentre trials of CHART vs conventional radiotherapy in head and neck and non-small-cell lung cancer: An interim report—CHART Steering Committee. Br J Cancer 73:1455-1462, 1996[Medline] 30. Belani CP, Wang W, Johnson DH, et al: Induction chemotherapy followed by standard thoracic radiotherapy (Std.TRT) vs. hyperfractionated accelerated radiotherapy (HART) for patients with unresectable stage III A and B non-small cell lung cancer (NSCLC): Phase III study of the Eastern Cooperative Oncology Group (ECOG 2597). Proc Am Soc Clin Oncol 22:622, 2003 (abstr 2500) 31. Gaspar L, Gandara D, Chansky K, et al: Consolidation docetaxel following concurrent chemoradiotherapy in pathologic stage IIIb non-small cell lung cancer (NSCLC) (SWOG 9504): Patterns of failure and updated survival. Proc Am Soc Clin Oncol 20:315a, 2003 (abstr 1255) Submitted November 15, 2004; accepted March 24, 2005.
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
10%, received two cycles of induction paclitaxel (200 mg/m2)/carboplatin (area under the plasma concentration time curve [AUC] = 6) followed by TRT 63.0 Gy (arm 1, sequential) or two cycles of induction paclitaxel (200 mg/m2)/carboplatin (AUC = 6) followed by weekly paclitaxel (45 mg/m2)/carboplatin (AUC = 2) with concurrent TRT 63.0 Gy (arm 2, induction/concurrent), or weekly paclitaxel (45 mg/m2)/carboplatin (AUC = 2)/TRT (63.0 Gy) followed by two cycles of paclitaxel (200 mg/m2)/carboplatin (AUC = 6; arm 3, concurrent/consolidation). 
RT) versus historical control. RT, radiotherapy.
