The Incidence and Clinical Characteristics of Interstitial Lung Disease Associated with CDK4/6 Inhibitors in Breast Cancer Patients: A Retrospective Multicenter Study
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Data Collection
2.2. Study Population
2.3. Ethical Approval
2.4. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Evaluation of the Characteristics of Patients Diagnosed with Interstitial Lung Disease Associated with CDK4/6 Inhibitors
Patient ID | ILD Subtype | CDK4/6 Inhibitor Type | Radiological |
---|---|---|---|
Findings | |||
Patient 1 | Hypersensitivity | Ribociclib | Upper lobe- |
Pneumonitis (HP) | predominant mosaic attenuation, air | ||
trapping, | |||
centrilobular | |||
nodules, and | |||
ground-glass | |||
opacities. (Figure 1) | |||
Patient 2 | Hypersensitivity | Ribociclib | Mosaic attenuation, air |
Pneumonitis (HP) | trapping, | ||
centrilobular | |||
nodules, and | |||
ground-glass | |||
opacities. Upper and middle lobe- | |||
predominant. | |||
Patient 3 | Hypersensitivity | Ribociclib | Bilateral lobe, air |
Pneumonitis (HP) | trapping, | ||
centrilobular | |||
nodules, and | |||
ground-glass | |||
opacities. (Figure 2) | |||
Patient 4 | Hypersensitivity | Ribociclib | Bilateral mosaic attenuation, air |
Pneumonitis (HP) | trapping, | ||
centrilobular | |||
nodules, and | |||
ground-glass | |||
opacities. | |||
Patient 5 | Nonspecific | Ribociclib | |
Interstitial | Bilateral | ||
Pneumonia (NSIP) | symmetrical | ||
ground-glass | |||
opacities, reticular densities, and | |||
traction | |||
bronchiectasis. | |||
Patient 6 | Nonspecific | Palbociclib | Bilateral |
Interstitial Pneumonia (NSIP) | symmetrical | ||
ground-glass | |||
opacities, reticular densities, and | |||
traction | |||
bronchiectasis. (Figure 3) | |||
Patient 7 | Nonspecific | Palbociclib | Lower lobe- |
Interstitial | predominant, | ||
Pneumonia (NSIP) | bilateral | ||
symmetrical | |||
ground-glass | |||
opacities, reticular densities, and | |||
traction | |||
bronchiectasis. | |||
Patient 8 | Nonspecific | Palbociclib | Lower lobe- |
Interstitial | predominant, | ||
Pneumonia (NSIP) | bilateral | ||
symmetrical | |||
ground-glass | |||
opacities, reticular densities, and | |||
traction | |||
bronchiectasis. | |||
Patient 9 | Acute Interstitial Pneumonia/ARDS (AIP-ARDS) | Palbociclib | Ground-glass opacities, |
consolidations, and honeycombing. (Figure 4) | |||
Patient 10 | Acute Interstitial Pneumonia/ARDS (AIP-ARDS) | Palbociclib | Diffuse ground-glass opacities, |
consolidations, and honeycombing. |
3.3. Evaluation of Characteristics of Patients Diagnosed with Interstitial Lung Disease Associated with CDK4/6 Inhibitors
4. Discussion
Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Parameter | Value | |
---|---|---|
Metastatic Breast Cancer Patients | (n = 464) | |
Gender | Male Patients | 4 (0.9%) |
Female Patients | 460 (99.1%) | |
Age (Mean ± Standard Deviation) | Age at Initiation of CDK4/6i Therapy (Years) | 59.06 ± 13.18 |
ECOG Performance Status | ||
At Diagnosis | ||
0 | 309 (66.6%) | |
1 | 132 (28.4%) | |
2 | 23 (5%) | |
Before CDK4/6i Therapy | ||
0 | 255 (55%) | |
1 | 150 (32.3%) | |
2 | 56 (12.1%) | |
3 | 3 (0.6%) | |
Line of CDK4/6i Therapy | ||
1 | 302 (65.1%) | |
2 | 97 (20.9%) | |
3 and later | 65 (14.0%) | |
Type of CDK4/6 Inhibitor | ||
Ribociclib | 253 (54.5%) | |
Palbociclib | 205 (44.2%) | |
Sequential Use of Ribociclib and Palbociclib | 6 (1.3%) | |
Endocrine Therapy Used with CDK4/6 Inhibitors | ||
Letrozole | 297 (64%) | |
Fulvestrant | 161 (34.7%) | |
Other | 6 (1.3%) | |
Chemotherapy Status | ||
Before CDK4/6i Therapy | ||
Neoadjuvant Chemotherapy | 140 (30.2%) | |
Adjuvant Chemotherapy | 75 (16.2%) | |
Metastatic Chemotherapy | 12 (2.6%) | |
No Chemotherapy | 227 (48.9%) | |
Metastatic Sites Before CDK4/6i Therapy | ||
Bone | 384 (82.2%) | |
Lymph Node | 206 (44.4%) | |
Lung | 164 (35.3%) | |
Liver | 109 (23.5%) | |
Soft Tissue | 52 (11.2%) | |
Pleura | 36 (7.8%) | |
Brain | 29 (6.3%) | |
Skin | 12 (2.6%) | |
Peritoneum | 9 (1.9%) | |
Smoking Status | ||
Current Smoker | 14 (3%) | |
Former Smoker | 119 (25.6%) | |
Never Smoked | 331 (71.3%) | |
ILD Associated with CDK4/6i | ||
Yes | 10 (2.2%) | |
No | 454 (97.8%) | |
Follow-up Duration (Months) | Median (Min–Max) | 72.2 (4.1–334.8) |
Mean ± Standard Deviation | 92.9 ± 70.7 |
Interstitial Lung Disease Associated with CDK4/6 Inhibitor | |||
---|---|---|---|
Parameter | No (n = 454) | Yes (n = 10) | p-Value |
Gender (Female) | 450 (99.1%) | 10 (100%) | 1.000 a |
Age at Initiation of CDK4/6i Treatment (Years) (Mean ± Standard Deviation) | 56.9 ± 12.6 | 53 ± 13.3 | 0.251 b |
Age at Start of CDK4/6i Treatment | |||
≤55 Years | 200 (44.1%) | 2 (20%) | 0.129 c |
>55 Years | 254 (55.9%) | 8 (80%) | |
CDK4/6i Treatment | |||
Ribociclib | 249 (54.8%) | 4 (40%) | 0.523 c |
Palbociclib | 199 (43.8%) | 6 (60%) | 0.349 c |
Sequential Use of Ribociclib and Palbociclib | 6 (1.3%) | 0 (0%) | 1.000 a |
Pre-existing ILD | |||
Yes | 4 (0.9%) | 0 (0%) | 0.152 a |
No | 450 (99.1%) | 10 (100%) | |
Smoking Status | |||
Current Smoker | 14 (3.1%) | 0 (0%) | 0.047 * c |
Former Smoker | 119 (26.2%) | 0 (0%) | |
Never Smoked | 321 (70.7%) | 10 (100%) | |
Menopause Status Before CDK4/6i | |||
Postmenopausal | 321 (70.7%) | 9 (90%) | 0.183 a |
Premenopausal | 133 (29.3%) | 1 (10%) | |
History of Radiation to the Chest Area | |||
Yes | 228 (50.2%) | 5 (50%) | 0.989 c |
No | 226 (49.8%) | 5 (50%) | |
Chemotherapy Status Before CDK4/6i Therapy | |||
Yes | 232 (51.1%) | 5 (50%) | 0.945 c |
No | 222 (48.9%) | 5 (50%) | |
Line of CDK4/6i Treatment | |||
1st Line | 296 (65.2%) | 6 (60%) | 0.858 c |
2nd Line | 95 (20.9%) | 2 (20%) | |
3rd and Subsequent Lines | 63 (13.9%) | 2 (20%) | |
Lung Metastasis | |||
Yes | 158 (34.8%) | 6 (60%) | 0.099 c |
No | 296 (65.2%) | 4 (40%) |
Pt ID | Age (Yrs) | CDK4/6i | Tx Line | PS | Lung Metastasis | Bone Metastasis | Smoking Status | Menopause | Pulm Comorbidity | Chest RT | Chemo Prior CDK4/6i | CerbB2 | ILD Type | ER/PR Status |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 59 | R | 1 | 1 | Y | Y | N | Post | N | N | N | 0 | HP | ER 100%/PR + |
2 | 62 | R | 2 | 2 | N | Y | N | Post | N | Y | Y | 0 | HP | ER 100%/PR (+) |
3 | 67 | P | 1 | 1 | Y | Y | N | Post | N | Y | Y | 0 | HP | ER 80%/PR (+) |
4 | 58 | R | 1 | 0 | Y | Y | N | Post | Y | N | N | 0 | HP | ER 90%/PR (+) |
5 | 68 | P | 2 | 0 | N | Y | N | Post | N | Y | Y | 0 | NSIP | ER 100%/PR (+) |
6 | 49 | P | 1 | 0 | Y | Y | N | Post | N | Y | Y | 0 | NSIP | ER 100%/PR (+) |
7 | 70 | P | 1 | 1 | N | Y | N | Post | N | N | N | 1 | NSIP | ER 95%/PR (+) |
8 | 63 | P | 3 | 2 | Y | Y | N | Post | Y | N | N | 1 | NSIP | ER 100%/PR (+) |
9 | 81 | P | 1 | 2 | N | Y | N | Post | N | N | N | 1 | AIP-ARDS | ER 98%/PR (+) |
10 | 48 | R | 3 | 0 | Y | Y | N | Pre | N | Y | Y | 1 | AIP-ARDS | ER 50%/PR (-) |
Pt ID | CDK4/6i Tx | ET | Time to Onset (Days) | ILDG. | Management | Steroid | Supportive Tx | Resolution (Days) | Death |
---|---|---|---|---|---|---|---|---|---|
1 | Ribociclib (1st line) | Letrozole | 88 | 3 | Discontinued | Yes | Oxygen support | 21 | No |
2 | Ribociclib (2nd line) | Fulvestrant | 161 | 3 | Discontinued | Yes | Oxygen support, | 24 | No |
antibiotics | |||||||||
3 | Palbociclib (1st line) | Letrozole | 249 | 3 | Discontinued | Yes | ICU admission, oxygen support, | N/A | Yes |
antibiotics, MMF, infliximab | |||||||||
4 | Ribociclib (1st line) | Letrozole | 123 | 3 | Discontinued | Yes | Oxygen support | 35 | No |
5 | Palbociclib (2nd line) | Fulvestrant | 111 | 3 | Discontinued | Yes | Oxygen support | 37 | No |
6 | Palbociclib (1st line) | Letrozole | 479 | 4 | Discontinued | Yes | Oxygen support | 42 | No |
7 | Palbociclib (1st line) | Letrozole | 276 | 3 | Discontinued | Yes | Oxygen support, MMF, persistent pulmonary dysfunction | N/A | No |
8 | Palbociclib (3rd line) | Letrozole | 581 | 4 | Discontinued | Yes | Oxygen support | 28 | No |
9 | Palbociclib (1st line) | Letrozole | 73 | 3 | Discontinued | Yes | Oxygen support, antibiotics | 45 | No |
10 | Palbociclib (3rd line) | Letrozole | 113 | 3 | Resumed with Dose Reduction | Yes | Oxygen support | 30 | No |
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İlhan, N.; Doğan, A.; Erölmez, H.N.; Atalah, F.; Baş, S.; Yasar, S.; Odabaş, H.; Gümüş, M. The Incidence and Clinical Characteristics of Interstitial Lung Disease Associated with CDK4/6 Inhibitors in Breast Cancer Patients: A Retrospective Multicenter Study. Medicina 2025, 61, 549. https://doi.org/10.3390/medicina61030549
İlhan N, Doğan A, Erölmez HN, Atalah F, Baş S, Yasar S, Odabaş H, Gümüş M. The Incidence and Clinical Characteristics of Interstitial Lung Disease Associated with CDK4/6 Inhibitors in Breast Cancer Patients: A Retrospective Multicenter Study. Medicina. 2025; 61(3):549. https://doi.org/10.3390/medicina61030549
Chicago/Turabian Styleİlhan, Nurullah, Akif Doğan, Hande Nur Erölmez, Fatih Atalah, Süleyman Baş, Servan Yasar, Hatice Odabaş, and Mahmut Gümüş. 2025. "The Incidence and Clinical Characteristics of Interstitial Lung Disease Associated with CDK4/6 Inhibitors in Breast Cancer Patients: A Retrospective Multicenter Study" Medicina 61, no. 3: 549. https://doi.org/10.3390/medicina61030549
APA Styleİlhan, N., Doğan, A., Erölmez, H. N., Atalah, F., Baş, S., Yasar, S., Odabaş, H., & Gümüş, M. (2025). The Incidence and Clinical Characteristics of Interstitial Lung Disease Associated with CDK4/6 Inhibitors in Breast Cancer Patients: A Retrospective Multicenter Study. Medicina, 61(3), 549. https://doi.org/10.3390/medicina61030549