International Journal of Radiation Oncology*Biology*Physics
Clinical investigationLungStereotactic body radiation therapy of early-stage non–small-cell lung carcinoma: Phase I study
Introduction
Lung cancer remains in North America the most frequent cause of cancer death in both men and women. It was estimated that there will be 173,770 new lung cancer cases in the United States in the year 2004 with an estimated 160,440 deaths due to this highly lethal malignancy. This accounts for approximately 13% of all cancers diagnosed but 28% of all cancer deaths (2). Approximately 25% of patients present with Stage I or II disease. Optimally, the definitive management of these cases of early-stage lung carcinoma is considered to be surgical with a 50%–80% 5-year survival (3, 4). In contrast, the management of those patients with early-stage bronchogenic carcinoma deemed medically inoperable is less clear. Involved-field radiotherapy is generally considered the treatment of choice for those patients who cannot undergo surgery (4, 5), but 5-year survival after radiotherapy alone is less than approximately half of that achieved by wide surgical resection.
In a preliminary report, we presented the outcome of the first 33 patients entered on a Phase I study of high-dose-per-fraction, stereotactically targeted radiation therapy for patients with Stage I lung cancer who were considered medically inoperable (13). With a median follow-up of 15.2 months, patients had tolerated the therapy well. We now present further results from the completed trial, which included 47 patients, with an assessment of patterns of failure in these frail patients.
Section snippets
Patients
Patients included were diagnosed with non–small-cell lung carcinoma (NSCLC) by biopsy, or they were cytologically staged as AJCC Stage 1A or 1B. Eligible diagnoses included squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, bronchoalveolar cell carcinoma, or non–small-cell not otherwise specified. Patients had no direct evidence of regional or distant metastases after appropriate staging studies. All patients were assessed for surgery by a thoracic surgeon and deemed medically
Patient characteristics
Between January 2000 and January 2003, 47 patients were accrued to the study. The median Karnofsky performance score was 70 with 14 oxygen-dependent patients. Demographics and main reasons for medical inoperability are shown in Table 1. For Stage T1 patients, the mean GTV treated was 8.51 cc, and for Stage T2 patients, mean GTV was 50.5 cc.
For the T1 tumor group, partial responses were seen in all tumors with complete responses in 7/19 patients. Tumor shrinkage greater than 50% was seen in
Discussion
Surgery is the preferred form of treatment for early-stage NSCLC with many reviews showing a 50%–80% 5-year survival (4, 5). Local radiotherapy to a limited volume of tissue is considered the standard therapy for patients with Stage I or II NSCLC who do not receive surgery, because of refusal or medical comorbidity; however, no randomized trials to compare the outcome of radiotherapy to observation only have been done. McGarry et al. (8) reviewed early-stage NSCLC patients managed by
References (17)
- et al.
The effect of surgical treatment on survival from early lung cancerImplications for screening
Chest
(1992) - et al.
Involved field radiotherapy alone for early stage non-small-cell lung cancer
Int J Radiat Oncol Biol Phys
(2000) - et al.
Strategy for lymphadenectomy in lung cancer 3 cm or less in diameter
Ann Thorac Surg
(1990) - et al.
Observation-only management of early stage medically inoperable lung cancerPoor outcome
Chest
(2002) - et al.
A new approach to dose escalation in non-small cell lung cancer
Int J Radiat Oncol Biol Phys
(2001) - et al.
Can tumor size be a guide for limited surgical resection in patients with peripheral non-small cell lung cancer? Assessment from the point of view of nodal micrometastasis
J Thorac Cardiovasc Surg
(2001) - et al.
Radiotherapy alone for medically inoperable Stage I non-small cell lung cancerThe Duke experience
Int J Radiat Oncol Biol Phys
(1998) - et al.
Extracranial stereotactic radioablationResults of a phase I study in medically inoperable stage I non-small cell lung cancer patients
Chest
(2003)
Cited by (438)
Tumor hypoxia and radiotherapy: A major driver of resistance even for novel radiotherapy modalities
2024, Seminars in Cancer BiologyPrecise dosimetric comparison between GAMOS and the collapsed cone convolution algorithm of 4D DOSE accumulated in lung SBRT treatments
2023, Radiation Physics and ChemistryRealDRR – Rendering of realistic digitally reconstructed radiographs using locally trained image-to-image translation
2020, Radiotherapy and Oncology