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(Chest. 2000;117:127S-132S.)
© 2000 American College of Chest Physicians

Combined Modality Therapy for Unresectable Stage III Non-Small Cell Lung Cancer*

New Chemotherapy Combinations

Chandra P. Belani, MD

* From the Division of Medical Oncology, Department of Medicine, University of Pittsburgh School of Medicine and University of Pittsburgh Cancer Institute, Pittsburgh, PA.

Correspondence to: Chandra P. Belani, MD, University of Pittsburgh Cancer Institute, 200 Lothrop St, MUH N-725, Pittsburgh, PA 15213; e-mail: belanicp{at}msx.upmc.edu


   Abstract
TOP
 Abstract
Introduction
 Concurrent Chemoradiation
 Concurrent Chemotherapy and TRT...
 Discussion
 References
 
Over the last decade, we have witnessed improved outcome among patients with non-small cell lung cancer (NSCLC), principally through the use of new and novel treatment programs. A meta-analysis of randomized clinical trials comparing combined chemotherapy and radiation to radiation therapy alone clearly has shown a survival benefit with platinum-based combination chemotherapy administered sequentially or concurrently with thoracic radiation therapy over radiation therapy alone. In addition, combining thoracic radiation therapy with novel drugs or new drug combinations has yielded improvements in median survival duration and long-term survival rates in locally advanced unresectable NSCLC. Paclitaxel and carboplatin are two novel agents that have undergone extensive clinical evaluation at various doses and schedules in combination with thoracic radiation therapy in patients with locally advanced disease. There remains a need, however, for further improvement in metastatic control and prevention of locoregional recurrences. This will likely be achieved through the optimization of chemotherapy regimens to be used in combined modality therapy with thoracic radiation therapy.

Key Words: combined modality • esophagitis • non-small cell lung cancer • radiosensitization • survival • therapy • thoracic radiation


   Introduction
TOP
 Abstract
 Introduction
Concurrent Chemoradiation
 Concurrent Chemotherapy and TRT...
 Discussion
 References
 
Thoracic radiation therapy (TRT) by itself provides local control and effective palliation of symptoms, but has minimal effect on survival for patients with locally advanced unresectable stage III non-small cell lung cancer (NSCLC).1 2 3 Novel schemes of radiation such as hyperfractionated radiation (HRT)4 and continuous hyperfractionated accelerated radiotherapy (CHART)5 6 appear promising. The recommended dose for HRT in unresectable NSCLC is 69.6 Gy as established by a Radiation Therapy Oncology Group study.4 Saunders et al6 demonstrated that the CHART regimen (54 Gy in 36 fractions over 12 continuous days) was superior to conventional TRT in the treatment of patients with NSCLC, but was associated with substantial esophagitis.

Addition of chemotherapy to TRT sequentially,7 8 9 10 or concurrently11 12 13 has shown an impact on survival among patients with unresectable NSCLC, especially those with good performance status and < 5% weight loss,8 9 10 compared to TRT alone (Table 1 ). In the study by Dillman et al,8 9 comparing cisplatin, 100 mg/m2 (days 1 and 29), and vinblastine, 5 mg/m2 (days 1, 8, 15, 22, and 29), followed by TRT beginning on day 50 (60 Gy) vs TRT alone, the median survival duration of 13.7 months in the combined modality arm was significantly better than the 9.6 months observed in the TRT alone arm (p = 0.01), and there were more than twice the number of survivors at 3, 4, and 5 years. This study was duplicated by the Radiation Therapy Oncology Group and the Eastern Cooperative Oncology Group with addition of a third arm utilizing HRT 69.6 Gy.10 The 1-year survival rate and median survival duration were significantly better in the combined modality arm (60% and 13.8 months, respectively) than in the arms that received HRT alone (51%, 12.3 months) or standard TRT (46%, 11.4 months; p = 0.03). The difference between the 1-year survival rate achieved with standard TRT and that achieved with HRT was not significant. A French group also demonstrated a survival benefit and improved systemic control, as marked by a reduction in distant metastases, with chemotherapy plus sequential TRT compared with TRT alone.7


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  		Table 1. Randomized Trials of Sequential Chemotherapy and TRT in Locally Advanced Inoperable NSCLC*

 

   Concurrent Chemoradiation
TOP
 Abstract
 Introduction
 Concurrent Chemoradiation
Concurrent Chemotherapy and TRT...
 Discussion
 References
 
Administering radiosensitizing chemotherapy concurrently with TRT may further improve locoregional control. A number of randomized studies have examined radiosensitizing doses of platinum compounds combined with concurrent TRT (Table 1) .11 12 13 In a three-arm study, Schaake-Koning et al11 used split-course TRT in the treatment of 330 patients with inoperable NSCLC. The first group received 30 Gy TRT over 2 weeks followed by a 3-week rest period, plus an additional 25 Gy TRT administered over 2 weeks; the second group received the same TRT dose and schedule, to which concurrent cisplatin, 30 mg/m2, was added on the first day of each treatment week; a third group received the same TRT with cisplatin, 6 mg/m2, given daily before each radiation fraction. The 3-year survival rate was 2% in the TRT arm, compared with 13% in the group receiving TRT and weekly cisplatin (p = 0.36). The daily cisplatin/TRT arm demonstrated significantly improved survival compared with the TRT-only arm (p = 0.009). The addition of chemotherapy to TRT did not increase the incidence of esophagitis in this study; however, nausea and vomiting were a significant problems, affecting approximately 70% of patients who received cisplatin chemotherapy plus TRT, compared with only 24% who received TRT alone.

Concurrent chemotherapy and HRT was evaluated by Jeremic et al12 13 in two randomized studies. In the first study,12 patients with stage III NSCLC received HRT 64.8 Gy either alone, with concurrent weekly carboplatin, 100 mg on days 1 and 2, and etoposide, 100 mg on days 1 to 3, added, or with concurrent carboplatin, 200 mg on days 1 and 2, and etoposide, 100 mg on days 1 to 5, given in the first, third, and fifth weeks of TRT. Median and 3-year survivals were highest in the group that received HRT with the lower dose of weekly carboplatin and etoposide (18 months and 23%, respectively). The 3-year survival in this group approached statistical significance, compared with the group that received HRT alone (6.6%; p = 0.0027). In their second study,13 the total dose of HRT was increased to 69.6 Gy (given as 1.2 Gy bid); in one group, concurrent chemotherapy with carboplatin and etoposide (both given at doses of 50 mg IV) was given prior to each radiation fraction. Median and 4-year survivals were 22 months and 23%, respectively, in the combined modality arm vs 14 months and 9% in the HRT only arm (p = 0.021 for differences in 4-year survival). The two groups showed similar rates of acute and late high-grade toxic reactions. Thus, concurrent chemotherapy enhanced the effect of TRT and significantly improved local control compared with HRT alone (4-year local recurrence-free survival, 42% vs 19%, respectively; p = 0.015).

A meta-analysis of randomized studies comparing the efficacy of TRT alone to combined chemotherapy and TRT in patients with locally advanced, unresectable NSCLC14 showed the relative risk for death at 1, 2, and 3 years to be reduced by 12, 13, and 17%, respectively, in the combined modality therapy group. The benefit of chemotherapy appeared to increase with time, reaching a maximum at 31 to 36 months after start of treatment. The mean gain in life expectancy was approximately 2 months at the end of 3 years, with median survival improved by 1.7 months. Although chemotherapy did not impair delivery of TRT, serious toxic effects, particularly febrile neutropenia and GI disturbances, were more prevalent among patients receiving cisplatin-based chemotherapy. Thus, the addition of chemotherapy to TRT offers an advantage in patients with locally advanced, unresectable stage III NSCLC, but the optimal and most effective chemotherapeutic regimen is not known. The other controversy revolves around the ways of integrating chemotherapy and radiotherapy.


   Concurrent Chemotherapy and TRT Using Carboplatin/Paclitaxel
TOP
 Abstract
 Introduction
 Concurrent Chemoradiation
 Concurrent Chemotherapy and TRT...
Discussion
 References
 
In an attempt to decrease the toxicity of cisplatin-based chemoradiation, we conducted a pilot study using weekly carboplatin (a less toxic analog of cisplatin) plus TRT to treat patients with locally advanced NSCLC.15 In this study, 35 previously untreated patients with stage III NSCLC were given weekly carboplatin, 100 mg/m2, with concurrent TRT (total dose, 60 Gy), yielding a response rate of 34% and median survival duration of 13 months. The treatment was well tolerated, with only three patients requiring treatment prolongations of > 1 week. This regimen was active, with mild toxicities and suitable for combination with other chemotherapeutic agents.

Paclitaxel is a known radiosensitizer,16 17 and a novel agent with a wide spectrum of activity in advanced and metastatic NSCLC.18 It has shown impressive single-agent activity,19 20 as well as activity in combination therapy with carboplatin.21 22 23 24 A phase I study by Choy et al25 established that the maximum-tolerated dose of paclitaxel in locally advanced NSCLC was 60 mg/m2, with concurrent TRT of 60 Gy. Although there is evidence that p53 mutations herald a poor response to chemotherapy in patients with NSCLC,26 one report suggests that they do not predict response to a regimen of concurrent TRT and paclitaxel, and that this combination may be effective even in patients with locally advanced tumors with high rates of p53 mutations.27

Based on these observations, we designed a phase II trial incorporating weekly paclitaxel into our regimen of weekly carboplatin plus concurrent TRT for patients with stage III NSCLC.28 The paclitaxel dose was 45 mg/m2/wk based on its potential to act as radiosensitizer at relatively low concentrations. Thirty-eight patients received paclitaxel, 45 mg/m2 over 3 h, with standard premedication followed by carboplatin, 100 mg/m2 over 30 min, both given IV. Concurrent TRT was given to a total of 60 to 65 Gy over 6 to 7 weeks (Table 2 ).


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  		Table 2. Phase II Trial of Weekly Paclitaxel/Carboplatin Plus Concurrent TRT: Treatment Regimen*

 
Toxicity was monitored during weekly patient visits for chemotherapy. Dose modifications were made in the event of neutropenia, mucositis, or esophagitis. Radiographic response was evaluated 4 weeks after completion of all treatment. Approximately two thirds of the patients had stage IIIB disease, and the rest had macroscopic stage IIIA (N2) disease (Table 3 ). Adenocarcinoma and squamous cell carcinoma were the most common histologies.


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  		Table 3. Phase II Trial of Weekly Paclitaxel/Carboplatin Plus Concurrent TRT: Patient Characteristics*

 
Overall, the regimen was well tolerated and toxicities have been manageable; no grade 4 toxicities occurred in 38 evaluable patients. Dose reduction was necessary in 12 instances, and treatment was delayed > 1 week in five patients. Only two patients developed grade 3 mucositis and esophagitis; three patients died as a result of rapidly progressive disease without any evidence of dose-limiting toxicities (Table 4 ).


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  		Table 4. Phase II Trial of Weekly Paclitaxel/Carboplatin Plus Concurrent TRT: Grade 3/4 Toxicities*

 
The preliminary results from this study indicate that combination of paclitaxel/carboplatin plus concurrent radiotherapy is feasible in stage IIIA/IIIB unresectable, regionally advanced NSCLC. In general, toxicity associated with this treatment regimen was acceptable. The combined modality regimen using concurrent chemotherapy and radiotherapy was active, with promising long-term survival (Table 5 ).


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  		Table 5. Phase II Trial of Weekly Paclitaxel/Carboplatin Plus Concurrent TRT: Survival

 
Choy and colleagues29 30 reported results utilizing their regimen of paclitaxel, 50 mg/m2 by 1-h infusion weekly; carboplatin weekly, with a dose targeted to achieve an area under the plasma concentration-vs-time curve (AUC) of 2, and concurrent TRT to a total of 66 Gy. Patients then went on to receive two additional cycles of chemotherapy (Table 6 ). The overall response rate among 37 evaluable patients was 75%, and the 1- and 2-year survival rates were 54% and 40%, respectively. The incidence of esophagitis (grade 3 to 4) was 49% but was of short duration. Other rare toxicities included nausea, vomiting, neuropathy, weight loss, and pulmonary complications. Based on these encouraging results, the same doses of weekly paclitaxel and carboplatin plus HRT are being utilized in a current study being performed by Choy and colleagues.31


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  		Table 6. Vanderbilt University Multicenter Phase II Trial

 
Investigators at the Fox Chase Cancer Center32 designed a study to test induction therapy with full-dose paclitaxel and carboplatin (with growth factor support), followed by two cycles of escalating doses of concurrent carboplatin and paclitaxel (day 43 and 64) with TRT. The response to induction therapy has been 38%, but the overall response rate after both phases is 59%. Paclitaxel, 175 mg/m2, has been tolerated with carboplatin dose targeted to achieve an AUC of 3.75 during the concurrent phase (Table 7 ). Inferences regarding toxicity, especially esophagitis, cannot be made from this study because it is a dose-escalation trial. Nevertheless, these investigators have shown that the length of esophagus exposed to the radiation field is an important factor resulting in esophagitis, especially with combined modality regimens.33


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  		Table 7. Induction and Concurrent Paclitaxel and Carboplatin With Thoracic Radiation in Stage III NSCLC: Fox Chase Cancer Center Experience*

 

   Discussion
TOP
 Abstract
 Introduction
 Concurrent Chemoradiation
 Concurrent Chemotherapy and TRT...
 Discussion
References
 
Carboplatin and paclitaxel have been successfully integrated with TRT for patients with locally advanced unresectable NSCLC, and early results have shown improved outcome. Both sequential and concurrent regimens are feasible and the toxicity profiles are acceptable.

Concurrent chemoradiotherapy incorporating low doses of weekly paclitaxel and carboplatin is not only feasible but also effective in prolonging survival of patients with locally advanced NSCLC. The dose and schedule of paclitaxel administration in the combined modality programs continues to be a subject of controversy. Based on preliminary results, the doses of paclitaxel 45 to 50 mg/m2/wk (1- or 3-h infusion) and carboplatin, 100 mg/m2 or AUC 2, can be combined with concurrent TRT for the treatment of locally advanced NSCLC. There appears to be no advantage to administering paclitaxel on a prolonged schedule, (eg, daily bolus during TRT).34 When cisplatin, 75 mg/m2, and full-dose paclitaxel, 135 mg/m2, were combined with concurrent TRT 64.8 Gy (34 fractions over 7 weeks) for patients with unresectable stage IIIA and IIIB NSCLC to assess treatment tolerability, efficacy, and survival,35 the major toxicities encountered were esophagitis and leukopenia. The investigators concluded that administration of larger/full doses of paclitaxel every 4 weeks with concurrent TRT could not be recommended for use because of prohibitive toxicity.

Administration of a larger dose of paclitaxel on a 3- to 4-week schedule in concurrent chemoradiotherapy programs provides the same dose intensity, but is clearly associated with prohibitive toxicity. The length of the esophagus included in the radiation field also should be minimized so as to avoid excessive toxicity.33

The patterns of failure in patients treated with concurrent paclitaxel, carboplatin, and thoracic radiation suggest the need for additional chemotherapy either at the front end or after the completion of the concurrent regimen. A large, multicenter, randomized study (Locally Advanced Multimodality Protocol; Table 8 ) has been initiated to address these issues of improvement in distant control and to further refine the combined modality approach for patients with locally advanced NSCLC. The hope for the immediate future is to define an effective and optimal regimen that can be given simultaneously with TRT, and that can result in improved local and systemic control in patients with regionally advanced NSCLC.


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  		Table 8. Randomized Study of Combined Modality Treatment in Locally Advanced NSCLC: Locally Advanced Multimodality Protocol*

 


   Footnotes
 
Abbreviations: AUC = area under the plasma concentration-vs-time curve; CHART = continuous hyperfractionated accelerated radiotherapy; HRT = hyperfractionated radiation; NSCLC = non-small cell lung cancer; TRT = thoracic radiation therapy


   References
TOP
 Abstract
 Introduction
 Concurrent Chemoradiation
 Concurrent Chemotherapy and TRT...
 Discussion
 References
 

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