Stage IB Non-small Cell Lung Research Articles

Carcinoma broncogénico no microcítico en estadio IB. Impacto del número de adenopatías analizadas en la supervivencia

Introduction and Objectives To determine the causes of death in patients operated on for stage IB non-small cell lung cancer (NSCLC) and to assess the impact on survival of the number of lymph nodes removed. Patients and Method We studied 300 patients operated on for stage IB NSCLC. Only palpable or visible lymph nodes were excised. Kaplan-Meier survival estimates were calculated and the survival curves were compared using the log-rank test. Results The mean (SD) age of the patients was 62.9 (9.7) years; 280 were men, 20 were women. Pneumonectomy was performed in 84 patients, lobectomy in 186, double lobectomy in 23, and segmentectomy in 7. Squamous cell carcinoma was the most common histologic type. The mean number of lymph nodes excised was 5.05 (5.01). At the time of the study 201 patients (67%) had died, 63.2% from causes related to the NSCLC. Overall 5-year survival for the patient series was 51.9% (median, 5.50 years; 95% confidence interval [CI], 4.14–6.87 years), though the 5-year survival rate was 61.87% after non-NSCLC–related deaths were excluded (median, 11.05 years; 95% CI, 7.63–14.48 years). Tumor size and the number of lymph nodes examined significantly affected survival. In the multivariate analysis, these 2 variables were also significantly correlated with the risk of death from NSCLC ( P<.0001), with relative risks of 1.158 (95% CI, 1.081–1.240) and 0.387 (95% CI, 0.254–0.591), respectively. Conclusion Besides being affected by stage and tumor size, survival in patients operated on for stage IB NSCLC is significantly influenced by the total number of lymph nodes examined. Therefore, surgical treatment of such patients should include the examination of as many lymph nodes as possible.

Adjuvant chemotherapy in stage IB non-small cell lung cancer: if, when, how?

Adjuvant chemotherapy is established as a standard of care for resectable non-small cell lung cancer. However, this indication remains controversial for the stage IB as the results of the randomized trials and meta-analysis are obscuring on this issue. Moreover, the updated international guidelines do not prescribe the regular use of this strategy in stage IB. The aim of this paper is to review the current evidences regarding the benefit of adjuvant CT in this setting, and to provide clinical hints, which can lend a helping hand to the clinicians and their patients to take the right decision in this particular scenario.

Identification of a low risk subgroup of stage IB lung adenocarcinoma patients

Several trials have recently reported the efficacy of adjuvant chemotherapy for resected stage IB non-small cell lung cancer (NSCLC). However, the histological findings and prognosis of stage IB lung adenocarcinoma vary considerably. The aim of this study was to investigate prognostic factors of resected stage IB adenocarcinoma and identify a subgroup with a better prognosis, in which adjuvant chemotherapy could be omitted. We reviewed 413 cases of stage I lung adenocarcinoma treated by surgical resection, and investigated prognostic factors that favorably affected the survival of 106 patients with stage IB lung adenocarcinoma. A subgroup with a better outcome was identified and their survival was compared with that of stage IA patients. The 5-year survival rate of the stage IB adenocarcinoma patients was 81.7%. Univariate analyses demonstrated that lymphatic permeation (p<0.001), vascular invasion (p=0.003), pleural invasion (p=0.001) and bronchioloalveolar carcinoma (BAC)-dominant histology (p=0.003) were significant prognostic factors. A multivariate analysis demonstrated that pleural invasion (p=0.02) was an independent prognostic factor. The 5-year survival rate of the stage IB adenocarcinoma patients without pleural invasion (76 cases) was 89.3%, and it was not statistically different from that of the stage IA patients (92.7%). The stage IB lung adenocarcinoma patients without pleural invasion had a favorable outcome that was almost the same as that of stage IA patients. Because adverse effects of chemotherapy are sometimes severe and unacceptable, adjuvant chemotherapy can be omitted for stage IB adenocarcinoma without pleural invasion.

Prognostic Significance of the Non–Size-Based AJCC T2 Descriptors: Visceral Pleura Invasion, Hilar Atelectasis, or Obstructive Pneumonitis in Stage IB Non-small Cell Lung Cancer Is Dependent on Tumor Size

<h3>Background</h3> The T2 descriptor for staging non-small cell lung cancer (NSCLC) contains several non–size-based criteria. It remains unknown whether the prognostic significance of these non–size-based criteria is dependent on tumor size. <h3>Methods</h3> A total of 10,545 patients with stage IB NSCLC from the California Cancer Registry between 1989 to 2003 were categorized into the following three nonoverlapping criteria: (1) tumor size (T2S); (2) visceral pleura invasion, hilar atelectasis, or obstructive pneumonitis (T2P); and (3) main bronchus involvement ≥ 2 cm from the carina (T2C). Univariate survival analyses were performed using the Kaplan-Meier method. Multivariate survival analyses were performed using Cox proportional hazards ratios. <h3>Results</h3> A total of 51.1% of patients with stage IB NSCLC were staged by T2S, 43.2% by T2P, and 5.7% by T2C; 2,224 stage IB patients (total, 21.1%; 18.9% T2P + 2.2% T2C) had tumors ≤ 3 cm in size. The 5-year survival rate and the median survival time of these stage IB patients with tumors ≤ 3 cm in size were as follows: T2P, 51.2% and 64 months, respectively; T2C, 49.0% and 58 months, respectively. These values were similar to the 53.2% 5-year survival rate and 67-month median survival time for patients with stage IA NSCLC (p = 0.40). Cox proportional hazards model revealed T2P of > 3 cm was a poor prognostic factor for survival (vs T2S; hazard ratio [HR], 1.16; 95% confidence interval [CI], 1.08 to 1.24). Conversely, T2P ≤ 3 cm was a favorable prognostic factor for survival (vs T2S; HR, 0.89; 95% CI, 0.82 to 0.96). T2C was not an independent prognostic factor for survival. <h3>Conclusions</h3> Prognostic significance of the non–size-based T2 descriptor T2P is dependent on tumor size.

Prognostic factors in resected stage I non–small cell lung cancer with a diameter of 3 cm or less: Visceral pleural invasion did not influence overall and disease-free survival

Resection is the treatment of choice for patients with stage I non-small cell lung cancer. Stage I non-small cell lung cancer has been further subdivided into IA (T1N0M0, tumor size < or = 3 cm without visceral pleural invasion) and IB (T2N0M0, tumor size > 3 cm or any size with visceral pleural invasion). The aim of this study was to evaluate the prognostic factors in patients with resected stage I non-small cell lung cancer with a diameter of 3 cm or less. We retrospectively reviewed the clinicopathologic characteristics of 445 patients with resected stage I non-small cell lung cancer with a diameter of 3 cm or less who were treated at Taipei Veterans General Hospital between 1980 and 2000. Disease-free survival, overall survival, and their predictors were analyzed. The 5- and 10-year overall survivals were 61.4% and 40.0%, respectively. The 5- and 10-year disease-free survivals were 74.5% and 73.4%, respectively. Tumor size, smoking index, and number of mediastinal lymph nodes dissected were significant predictors for both disease-free survival (P = .009, P = .002, and P = .006, respectively) and overall survival (P = .004, P < .001, and P = .001, respectively) in multivariate analyses. Visceral pleural invasion did not influence overall survival or disease-free survival. Tumor size, smoking index, and number of mediastinal lymph nodes dissected were prognostic factors for both overall survival and disease-free survival in resected stage I non-small cell lung cancer with a diameter of 3 cm or less. Small tumors (<3 cm) of stage IB (T2N0M0) non-small cell lung cancer with visceral pleural invasion should be treated as T1 disease and not T2 disease.

Y1-10: Adjuvant therapies: what we have learned in the last 5 years

Y1-10: Adjuvant therapies: what we have learned in the last 5 years

D5-01: Prognostic significance of molecular markers and clinical factors in stage ib non-small cell lung cancer (NSCLC): a laboratory companion study to CALGB 9633

D5-01: Prognostic significance of molecular markers and clinical factors in stage ib non-small cell lung cancer (NSCLC): a laboratory companion study to CALGB 9633

P3-227: Determinants of recurrence and survival in patients following surgery for stage IB non-small cell lung cancer

P3-227: Determinants of recurrence and survival in patients following surgery for stage IB non-small cell lung cancer

Impact of tumor size on survival in stage IB (T2N0M0) non-small cell lung cancer (NSCLC)

7557 Background: Patients with stage IB NSCLC have a relatively poor survival of ∼60% despite adequate surgical resection. The role of adjuvant chemotherapy in this disease remains controversial since the results of the IALT, JBR.10, ANITA and CALGB 9633 trials. It is important to risk stratify patients with Stage IB NSCLC and to offer adjuvant therapies to those at greatest risk for recurrence. Methods: We conducted a retrospective review of 216 consecutive, surgically treated patients with stage IB NSCLC. None of the patients received adjuvant chemotherapy. We studied the association of various clinical factors as well as tumor size and visceral pleural invasion upon tumor recurrence, disease free survival (DFS) and overall survival (OS) at 5 years. Results: Of 216 patients, 135 (62%) were male, 97 (45%) had adenocarcinoma, 115 (53%) had poorly differentiated tumors and the majority (88%) were treated with lobectomy. Visceral pleural invasion was noted in 37 (17%) patients. The 5 year OS and DFS rates were 59% and 54% respectively. Tumor size was = 4cm in 120 (56%) patients, 4.1–5 cm and &gt;5cm in 48 (22%) patients each. The 5 year DFS was 40% and 58% for tumors &gt; 5cm and = 5 cm respectively (p &lt; 0.01). The 5 year OS was 49% and 61% respectively for tumors &gt; 5cm and = 5cm. Pleural invasion was a predictor for DFS in the univariate analysis (p &lt; 0.01) but not for OS. In the multivariable analysis, tumor size = 5cm was the only independent predictor of improved DFS (HR 0.46, C.I. 0.25–.84) and OS (HR=0.43, C.I. 0.23–0.80). Age, gender, histology, differentiation and visceral pleural invasion did not impact upon survival. Conclusions: In stage IB NSCLC, tumors &gt; 5cm in diameter have a significantly worse prognosis. These findings if confirmed in other large series, make a case for subdividing Stage IB NSCLC. Tumor size appears to be the most important factor in risk stratification for patients with stage IB NSCLC. Hence patients with large tumors should be offered adjuvant therapy. No significant financial relationships to disclose.

Optimal Adjuvant Therapy for Non-Small Cell Lung Cancer—How to Handle Stage I Disease

The standard of care for resected stage II-IIIA non-small cell lung cancer (NSCLC) now includes adjuvant chemotherapy based on the results of three phase III studies using cisplatin-based regimens--the International Adjuvant Lung Trial, the National Cancer Institute of Canada JBR.10 trial, and the Adjuvant Navelbine International Trialist Association trial. The role of adjuvant chemotherapy for stage I disease remains controversial. A recent meta-analysis (the Lung Adjuvant Cisplatin Evaluation) showed potential harm with the addition of adjuvant cisplatin for stage IA disease and no survival benefit for this modality in stage IB disease. Updated results from the Cancer and Leukemia Group B 9633 trial, the only trial to focus exclusively on stage IB patients, no longer show a statistically significant survival benefit from adjuvant chemotherapy in this population, except for the subgroup of patients with larger tumors. It may be that trials have been underpowered to detect a small benefit for patients with stage IB disease, or there may really not be benefit to adding adjuvant therapy for this stage of disease. Additional markers, such as tumor size or the presence or absence of certain tumor proteins like ERCC1, may help to determine which patients with resected stage I NSCLC may benefit from adjuvant chemotherapy. Strategies such as inhibition of angiogenesis pathways and the epidermal growth factor receptor are under exploration.

Postsurgical chemotherapy in stage IB nonsmall cell lung cancer: Longterm survival in a randomized study

Postsurgical chemotherapy in stage IB nonsmall cell lung cancer: Longterm survival in a randomized study

Postsurgical chemotherapy in stage IB nonsmall cell lung cancer: Longterm survival in a randomized study

Postsurgical chemotherapy in stage IB nonsmall cell lung cancer: Longterm survival in a randomized study

Stage IB Nonsmall Cell Lung Cancers: Are They All the Same?

Stage IB Nonsmall Cell Lung Cancers: Are They All the Same?

The prognostic impact of tumor size in resected stage I non-small cell lung cancer: Evidence for a two thresholds tumor diameters classification

The current TNM staging system for non-small cell lung cancer subdivides stage IA and IB according to a tumor size threshold of 3 cm. Some authors have suggested that tumor size behaves as a continuous, but the optimal diameter thresholds to be adopted remain debated. We conducted a retrospective study on 548 patients who underwent a complete surgical resection at our institute for stage IA and IB non-small cell lung cancer according to the current TNM staging system. Univariate and multiaviate analysis of overall and disease-specific survival were performed. Stage IA had an overall 5 years survival of 67% and a 5 years disease-specific survival of 85%. Stage IB had an overall 5 years of 49% and 5 years disease-specific survival of 53%. Tumors <2 cm had a significantly better survival than tumors > or =2 cm (overall survival: p=0.007; disease-specific survival: p=0.026), as well as tumors ranging from 2 to 5 cm in comparison with larger ones (overall survival: p=0.031; disease-specific survival: p=0.013). No significant difference was found between groups ranging from 2 to 5 cm. Tumors of 2-5 cm had 57% higher probability of death in comparison with tumors <2 cm and tumors >5 cm had a probability of death 60% higher than tumor of 2-5 cm. Age and tumor size (two thresholds diameter classification) resulted independent variables at multivariate analysis. the definition of T factor in the staging system of non-small cell lung cancer should consider two cutoffs according to tumor size. Two and 5 cm represent appropriate thresholds diameters that define subgroups with significant different prognosis.

Adjuvant chemotherapy in stage IB non-small cell lung cancer (NSCLC): Update of Cancer and Leukemia Group B (CALGB) protocol 9633

7007 Background: In 2004, preliminary results of CALGB 9633 demonstrated statistically significant evidence that adjuvant chemotherapy with paclitaxel and carboplatin (PC) improved disease-free (DFS) and overall survival (OS) in resected stage IB NSCLC. Indeed, the study was closed early by the DSMB after a planned interim analysis demonstrated a p value for OS less than a prespecified stopping boundary. However, two larger trials, NCIC-JBR10 and ANITA, have shown significant OS advantages with adjuvant chemo, but failed to demonstrate improved survival in the stage IB subset. This report provides more mature data from CALGB 9633. Methods: InCALGB 9633, stage IB patients (pts) were randomized following resection to paclitaxel 200 mg/m2 and carboplatin AUC 6 q3wks ×4 cycles or to observation. While initially planned to accrue 500 pts, the accrual rate was &lt;50% of expected. Because slow accrual allowed longer observation times for each pt, the accrual target was reduced to 384 pts. OS is the primary endpoint. The redesigned study had 80% power to detect a hazard ratio (HR) of 0.67 after 150 observed deaths using a 1-tailed logrank test conducted at the 0.05 level of significance. Results: Between 9/15/96 and 11/26/03, 344 pts were randomized. Median follow-up is 54 mo. Demographics and toxicity has been previously reported (JCO Sup, 22:621a, 2004). The current intent-to-treat analysis shows a significant improvement in DFS favoring adjuvant chemo (HR=0.74; 90% 2-sided CI: 0.57–0.96; p=0.027). There is a trend toward improvement in OS that is not significant (HR=0.80; 90% CI: 0.60–1.07; p=0.10). There is, however, a significant advantage in 3-yr survival (79% vs. 70%; p=0.045). Five-yr survival is not different (60% vs. 57%; p=0.32), although median follow-up is &lt;5 yrs and CIs are wide. Continued follow-up is planned since only 131 of 150 deaths required for final analysis have been observed. Conclusions: This updated but “preliminary” analysis no longer shows a significant OS advantage for adjuvant chemotherapy in stage IB NSCLC. However, the re-designed study does not have adequate power to detect small differences in OS that may be clinically significant. Advantages in DFS and 3-yr survival support continued consideration of adjuvant PC in stage IB NSCLC. [Table: see text]

Postsurgical chemotherapy in stage IB nonsmall cell lung cancer: Long‐term survival in a randomized study

Although surgical resection is considered the adequate treatment in early stages of nonsmall cell lung cancer, long-term survival is not satisfactory and recurrence rate is high. We previously showed that postoperative chemotherapy at stage IB reduces recurrences and prolongs overall survival. We extended size and observation period of the study sample and performed a separate analysis for minimally resected patients. The trial was designed as a randomized, 2-armed study with postoperative adjuvant chemotherapy versus surgery alone as control group. All patients had stage IB disease (pT2N0) assessed after a radical surgical procedure (defined as anatomical or minimal). Chemotherapy consisted of cisplatin (100 mg/m2 day 1) and etoposide (120 mg/m2 days 1-3) for 6 cycles. The primary endpoint was overall survival; secondary endpoint was disease-free survival (DFS). One hundred and forty patients entered the study: 70 were assigned to the adjuvant chemotherapy group and 70 to the control group. Groups were homogeneous for conventional risk factors. There was no clinically significant morbidity associated to chemotherapy. Patients were followed for a mean period of 40.31 +/- 30.86 months. A significant difference in overall (p = 0.02) and disease-free (p = 0.0001) survival was observed between patients undergoing adjuvant chemotherapy vs. control group. Adjuvant chemotherapy significantly improved both overall (p = 0.02) and DFS (p = 0.003) of anatomically resected patients, but only the DFS (p = 0.02) of minimally resected patients. Our results confirm that adjuvant chemotherapy may have a real impact on long-term survival in patients with stage IB nonsmall cell lung cancer being this effect especially evident for those anatomically resected.

Stage IB Nonsmall Cell Lung Cancers: Are They All the Same?

There is renewed interest in adjuvant chemotherapy after complete resection of nonsmall cell lung cancer, including stage IB (T2N0) cancers. Given the heterogeneity of the T2 classification, we hypothesize that there are survival differences in patients with stage IB NSCLC based on specific histopathologic tumor characteristics. A retrospective evaluation of 119 consecutive patients from 1999 to 2004 with a pathologic diagnosis of T2N0 nonsmall cell lung cancer was performed. Patient follow-up was 97%. Overall survival and disease-free survival rates were calculated by the Kaplan-Meier method. Univariate analysis was performed using the log rank test and multivariate analysis by Cox's proportional hazard model. Data were significant if p < 0.05. The 4-year overall survival and disease-free survival rates were 62% and 60%, respectively. The local and distant recurrence rates were 5% and 18%, respectively. Tumor size (p = 0.001), histologic grade (p = 0.002), the Eastern Cooperative Oncology Group performance status (p = 0.002), angioinvasion (p = 0.03), and visceral pleural involvement (p = 0.02) were predictors of overall survival by univariate analysis. Multivariate analysis demonstrated increasing tumor size (1.26 [95% confidence intervals 1.12, 1.64]) and histologic grade (4.05 [95% confidence intervals 1.38, 11.90]) to be significant independent predictors of a worse overall survival. The 4-year survival of patients without any of these variables was 89% compared with 56% if one or more of these factors were present (p = 0.03). There is significant heterogeneity in the T2N0 class of nonsmall cell lung cancer. Risk stratification using specific histopathologic variables may help determine which patients will benefit most from adjuvant therapy.

PD-025 Prognostic role of Protease-Activated Receptor 1 (PAR-1) and 4(PAR-4) in Stage IB non-small cell lung cancer (NSCLC)

PD-025 Prognostic role of Protease-Activated Receptor 1 (PAR-1) and 4(PAR-4) in Stage IB non-small cell lung cancer (NSCLC)

Randomized Clinical Trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in Stage IB Non-Small Cell Lung Cancer (NSCLC): Report of Cancer and Leukemia Group B (CALGB) Protocol 9633

7019 Background: The value of adjuvant chemotherapy in resectable lung cancer remains controversial. The International Adjuvant Lung Trial (IALT) reported a modest but statistically significant survival advantage with cisplatin-based adjuvant chemotherapy in stages IA to III NSCLC. On the other hand, Adjuvant Lung Project Italy (ALPI) failed to demonstrate benefit for adjuvant chemotherapy in patients of similar stage. CALGB 9633 was designed to test the effectiveness of adjuvant chemotherapy in patients with T2N0M0, stage IB NSCLC. NCCTG and RTOG also participated. Methods: Within 4–8 weeks of resection, patients were randomized to adjuvant chemotherapy with paclitaxel 200 mg/m2 over 3 hours and carboplatin AUC 6, each administered on day one every three weeks for four cycles, or to observation. Eligibility: age >18 years, histologically documented NSCLC, T2 primary lesion, lobectomy or pneumonectomy, absence of tumor in N1 or N2 nodes sampled at surgery or mediastinoscopy. All p-values are two-sided. Results: Between 9/15/96 and 11/26/03, 344 patients were randomized. Median follow-up is currently 34 months. Median age was 61 years (range 34–81 years), and 64% were male. Groups were well balanced with regard to age, gender, race, ethnicity, histology, tumor differentiation, and resection type. 80% underwent mediastinoscopy prior to surgery. Lobectomy was performed in 89%. Adjuvant chemotherapy was well tolerated, and there were no chemotherapy-related toxic deaths. Grade III or IV neutropenia occurred in 36%. There have been 36 deaths from any cause among 173 patients in the chemotherapy group compared to 52 deaths among 171 patients in the observation group (HR=0.62; 95% CI: 0.41–0.95, p=0.028). Overall survival at 4 years is 71% (95% CI: 62%–81%) and 59% (95% CI: 50%–69%) in chemotherapy and observation groups, respectively. There was also a significant advantage in failure-free survival favoring the chemotherapy group (HR=0.69; 95% CI: 0.48–0.98; p=0.035). With regard to lung cancer mortality, there have been 19 lung cancer deaths in the chemotherapy group and 34 deaths in the control group (HR=0.51; 95% CI: 0.29–0.89; p=0.018). At 4 years, lung cancer mortality was 15% (95% CI: 8%–21%) and 26% (95% CI: 18%–34%) in chemotherapy and control groups, respectively. Conclusions: Adjuvant chemotherapy significantly reduces all-cause and lung cancer mortality in stage IB NSCLC. This is the first randomized trial to demonstrate significantly improved survival for a carboplatin-based adjuvant chemotherapy regimen in a uniform population with NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis

Randomized Clinical Trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in Stage IB Non-Small Cell Lung Cancer (NSCLC): Report of Cancer and Leukemia Group B (CALGB) Protocol 9633

7019 Background: The value of adjuvant chemotherapy in resectable lung cancer remains controversial. The International Adjuvant Lung Trial (IALT) reported a modest but statistically significant survival advantage with cisplatin-based adjuvant chemotherapy in stages IA to III NSCLC. On the other hand, Adjuvant Lung Project Italy (ALPI) failed to demonstrate benefit for adjuvant chemotherapy in patients of similar stage. CALGB 9633 was designed to test the effectiveness of adjuvant chemotherapy in patients with T2N0M0, stage IB NSCLC. NCCTG and RTOG also participated. Methods: Within 4–8 weeks of resection, patients were randomized to adjuvant chemotherapy with paclitaxel 200 mg/m2 over 3 hours and carboplatin AUC 6, each administered on day one every three weeks for four cycles, or to observation. Eligibility: age >18 years, histologically documented NSCLC, T2 primary lesion, lobectomy or pneumonectomy, absence of tumor in N1 or N2 nodes sampled at surgery or mediastinoscopy. All p-values are two-sided. Results: Between 9/15/96 and 11/26/03, 344 patients were randomized. Median follow-up is currently 34 months. Median age was 61 years (range 34–81 years), and 64% were male. Groups were well balanced with regard to age, gender, race, ethnicity, histology, tumor differentiation, and resection type. 80% underwent mediastinoscopy prior to surgery. Lobectomy was performed in 89%. Adjuvant chemotherapy was well tolerated, and there were no chemotherapy-related toxic deaths. Grade III or IV neutropenia occurred in 36%. There have been 36 deaths from any cause among 173 patients in the chemotherapy group compared to 52 deaths among 171 patients in the observation group (HR=0.62; 95% CI: 0.41–0.95, p=0.028). Overall survival at 4 years is 71% (95% CI: 62%–81%) and 59% (95% CI: 50%–69%) in chemotherapy and observation groups, respectively. There was also a significant advantage in failure-free survival favoring the chemotherapy group (HR=0.69; 95% CI: 0.48–0.98; p=0.035). With regard to lung cancer mortality, there have been 19 lung cancer deaths in the chemotherapy group and 34 deaths in the control group (HR=0.51; 95% CI: 0.29–0.89; p=0.018). At 4 years, lung cancer mortality was 15% (95% CI: 8%–21%) and 26% (95% CI: 18%–34%) in chemotherapy and control groups, respectively. Conclusions: Adjuvant chemotherapy significantly reduces all-cause and lung cancer mortality in stage IB NSCLC. This is the first randomized trial to demonstrate significantly improved survival for a carboplatin-based adjuvant chemotherapy regimen in a uniform population with NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis