ElderTac Study: Erlotinib, A Potential Palliative Treatment for Elderly Patients with Advanced NSCLC
Introduction
Non-small cell lung cancer (NSCLC) is usually diagnosed in advanced stages, when curative surgery is no longer feasible. The median age of NSCLC patients is 70 years and treatment is challenging because of the advanced age of patients. Limited studies have focused on elderly population with this condition.
Aim
ElderTac (erlotinib in routine clinical practice in elderly patients with NSCLC) investigated the effectiveness and tolerability of erlotinib in elderly patients with non-small-cell lung cancer (NSCLC) after ≥1 platinum-based chemotherapy.
Patient Profile
- N=385
- Age > 65 years
- Advanced or metastatic UICC stage IV NSCLC confirmed by histological analysis
- Progressive disease on ≥1 platinum-based chemotherapy treatment
|
Patient Characteristics |
|
Patients, n (%) |
|
ECOG PS |
0 |
64 (16.6) |
|
|
1 |
210 (54.5) |
|
|
2 |
92 (23.9) |
|
|
3 |
3 (0.8) |
|
|
NR |
16 (4.2) |
|
Smoking Status |
Never smoked |
91 (23.7) |
|
|
Former smoker |
198 (51.4) |
|
|
Current smoker |
77 (20.0) |
|
|
NR |
19 (4.9) |
|
Tumor Histology |
Adenocarcinoma |
250 (64.9) |
|
|
Squamous cell carcinoma |
86 (22.3) |
|
|
Large cell carcinoma |
16 (4.2) |
|
|
Bronchoalveolar carcinoma |
11(2.9) |
|
|
Adenoid squamous cell carcinoma |
10 (2.6) |
|
|
Other |
12 (3.1) |
|
EGFR mutation status |
Tested |
119 (30.9) |
|
|
Positive |
18 (15.1) |
|
|
Wild-type |
98 (82.4) |
|
|
Indefinite |
3 (2.5) |
|
Previous chemotherapy |
Carboplatin |
279 (72.5) |
|
|
Cisplatin |
124 (32.2) |
|
|
Docetaxel |
54 (14.0) |
|
|
Gemcitabine |
96 (24.9) |
|
|
Paclitaxel |
56 (14.5) |
|
|
Vinorelbine |
92 (23.9) |
|
|
Other |
182 (47.3) |
ECOG: PS Eastern Cooperative Oncology Group Performance Status
EGFR: Epidermal Growth Factor Receptor Gene
Methods
- Prospective Non-interventional
- Non-comparative, single-arm surveillance study
- Patients received the recommended daily dose of 150 mg erlotinib
- Observation period was 12 months
Study Endpoints
- The 1-year overall survival (OS) rate
- 1-year progression-free survival (PFS) rate, PFS, objective response rate (ORR), disease control rate (DCR), symptom control, and adverse events (AE) were assessed
- The ORR was defined as the proportion of patients with at least a partial response
Results
- The 1-year OS rate was 31% with a median OS of 7.1 months
- OS was significantly better in females than males (p = 0.0258) and in patients with an EGFR mutation compared to EGFR wild-type patients (p = 0.0004).
|
|
ORR 3/6 months (%) |
DCR 3/6 months (%) |
Median PFS (months) |
Median OS (months) |
1-year OS (%) |
|
|
|
All patients (N = 385) |
|
|
|
|
Overall |
5.7/3.6 |
30.9/17.9 |
3.5 |
7.1 |
30.6 |
|
Gender |
|
|
|
|
|
|
Male |
5.8/2.7 |
31.8/16.7 |
3.4 |
6.3 |
25.4 |
|
Female |
5.5/5.5 |
29.1/20.5 |
4.1 |
8.1 |
41.8 |
|
Post-hoc analysis: Squamous cell histology (n = 86) |
|
|
|
|
|
|
Overall |
8.1/1.2 |
34.9/18.6 |
3.5 |
8.6 |
32.4 |
|
Male (n =66) |
6.1/1.5 |
33.3/16.7 |
3.5 |
8.6 |
28.7 |
|
Female (n = 20) |
15.0/0 |
40.0/25.0 |
4.4 |
9.5 |
44.5 |
|
Post-hoc analysis: Non-squamous EGFR wild-type (n = 91) |
|
|
|
|
|
|
Overall |
3.3/2.2 |
20.9/11.0 |
3.1 |
5.5 |
28.8 |
|
Gender |
|
|
|
|
|
|
Male (n =54) |
1.9/0 |
18.5/5.6 |
2.1 |
4.7 |
16.2 |
|
Female (n = 37) |
5.4/5.4 |
24.3/18.9 |
5.0 |
9.3 |
47.9 |
NSCLC non-small-cell lung cancer, OS overall survival, PFS progression-free survival, ORR objective response rate, DCR disease control rate,
- OS was not influenced by age (p = 0.3436) and ECOG PS (p = 0.5364)
- Patients with squamous NSCLC tended to live longer than patients with non-squamous EGFR wild-type tumors (median OS: 8.6 vs 5. 5 months)
Safety
- Cough and dyspnea improved during the observation period
- The erlotinib safety profile was comparable to that in previous studies with rash (45.2%) and diarrhea (22.6%) being the most frequently reported adverse events
- No new safety signals were observed
Conclusion
- The study findings suggested that erlotinib is an appropriate palliative treatment option in elderly patients with recurrent/advanced NSCLC particularly in patients with an activating EGFR mutation and squamous histology
- Erlotinib demonstrated efficacy and safety in routine clinical practice
- As the study was conducted in real life conditions , these results provide insights on benefits and risks of erlotinib in routine clinical practice
BMC Cancer (2018) 18:333
