Table 1
Patients and tumor characteristics.
| Items | Standard dose | Low dose | P value |
|---|---|---|---|
| Age (years) | |||
| Range | 40–59 | 38–64 | 0.87 |
| Mean ± SD | 49.5 ± 4.9 | 50.6 ± 7.2 | |
| Median | 49 | 50 | |
| Age groups | |||
| ≤45 years | 4 (19%) | 4 (21.1%) | 0.516 |
| >45 years | 17 (81%) | 15 (78.9%) | |
| Menopausal state | 8 (42.1%) | 0.971 | |
| Premenopausal | 11 (52.4%) | 11 (57.9%) | |
| Postmenopausal | 10 (47.6%) | ||
| PS | 4 (21.1) | 0.507 | |
| 0 | 5 (23.8%) | 10 (52.6%) | |
| 1 | 11 (52.4%) | 5 (26.3%) | |
| 2 | 5 (23.8%) | ||
| Surface area | 1.824 ± 0.18 | 1.795 ± 0.16 | 0.86 |
| Mean ± SD | |||
| Site of metastasis | |||
| Bone | 14 (66.7%) | 13 (68.4%) | 0.906 |
| Lung | 7 (33.3%) | 7 (36.8%) | 0.816 |
| Liver | 11 (52.4%) | 9 (47.4%) | 0.752 |
| Brain | 6 (28.6%) | 5 (26.3%) | 0.873 |
| LNs | 2 (9.5%) | 1 (5.3%) | 0.935 |
| No. of involved site | |||
| 1 | 6 (28.6%) | 7 (36.8%) | 0.84 |
| 2 | 8 (38.1%) | 6 (31.6%) | |
| > or =3 | 7 (33.3%) | 6 (31.6%) | |
| Hormonal state/Her 2 status | |||
| ER positive | 13 (61.9%) | 12 (63.2%) | 0.342 |
| PR positive | 12 (57.1%) | 8 (42.1%) | 0.302 |
| Her 2 positive | 4 (19%) | 5 (26.3%) | 0.58 |
| Triple negative | 5 (23.8%) | 4 (21.1%) | 0.83 |
| - | |||
| Initial stage | |||
| • Tumor stage | |||
| 2 | 8 (38.1%) | 10 (52.6%) | 0.312 |
| 3 | 11 (52.4%) | 9 (47.4%) | |
| 4 | 2 (9.5%) | 0 (0%) | |
| • Lymph node stage | |||
| 0 | 3 (14.3%) | 4 (21.1%) | 0.952 |
| 1 | 7 (33.3%) | 6 (31.6%) | |
| 2 | 7 (33.3%) | 6 (31.6%) | |
| 3 | 4 (19 %) | 3 (15.8%) | |
| • Grade | |||
| 1 | 2 (9.5%) | 1 (5.3%) | 0.754 |
| 2 | 11 (52.4%) | 12 (63.2%) | |
| 3 | 8 (38.1%) | 6 (31.6%) | |
| - Type | |||
| Infiltrating duct carcinoma | 17 (81%) | 17 (89.5%) | 0.664 |
| Infiltrating lobular carcinoma | 4 (19%) | 2 (10.5%) |
Table 2
Treatment characteristics.
| Items | Standard dose No. (%) | Low dose No. (%) | P value |
|---|---|---|---|
| Prior adjuvant/NA CTH | |||
| No | 3 (14.3%) | 2 (10.5%) | 0.899 |
| Anthracycline/taxanes | 13 (61.9%) | 11 (57.9%) | |
| Anthracycline + 5-FU | 5 (23.8%) | 6 (31.6%) | |
| Adjuvant HT | 14 (66.7%) | 11 (57.9%) | 0.567 |
| - Palliative CTH before capecitabine | |||
| Taxanes ± carboplatin | 2 (9.5%) | 3 (15.8%) | 0.587 |
| Navelbine ± FU | 2 (9.5%) | 4 (21.1%) | |
| Gem–cisplatin/carboplatin | 3 (14.3%) | 2 (10.5%) | |
| Others | |||
| - Palliative HT | 11 (52.4%) | 10 (52.6%) | 0.987 |
| Use of capecitabine | |||
| First | 14 (66.7%) | 9 (47.4%) | 0.417 |
| Second | 5 (23.8%) | 6 (31.6%) | |
| Third or more | 2 (9.5%) | 4 (21.1%) | |
| Median no. of cycles (range) | 6 (2–8) | 8 (4–10) | 0.762 |
| Dose reduction | 12 (57.1%) | 1 (5.3%) | <0.0005 |
| Cycle delay | 11 (52.3%) | 4 (21.1%) | 0.041 |
[i] CTH: chemotherapy; FU: fluorouracil; HT: hormonal treatment; NA: neoadjuvant.
Table 3
Treatment toxicities.
| Items | Standard dose no. (%) | Low dose no. (%) | P value | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| All | G 1 | G 2 | G 3 | All | G 1 | G 2 | G 3 | ||||
| - | HFS | 13 (61.9) | 7 (33.3) | 4 (19) | 2 (9.5) | 9 (47.3) | 7 (36.8) | 2 (10.5) | 0 | 0.42 | |
| - | Fatigue | 12 (57.1) | 8 (38) | 3 (14.2) | 1 (4.7) | 8 (42.1) | 6 (31.5) | 2 (10.5) | 0 | 0.66 | |
| - | Nausea | 7 (33.3) | 5 (23.8) | 1 (4.7) | 1 (4.7) | 4 (21) | 4 (21) | 0 | 0 | 0.94 | |
| - | Vomiting | 7 (33.3) | 4 (19) | 3 (14.2) | 0 | 4 (21) | 2 (10.5) | 2 (10.5) | 0 | 0.93 | |
| - | Diarrhea | 9 (42.8) | 4 (19) | 2 (9.5) | 3 (14.2) | 6 (31.5) | 5 (26.3) | 1 (5.2) | 0 | 0.58 | |
| - | Stomatitis | 7 (33.3) | 3 (14.2) | 3 (14.2) | 1 (4.7) | 4 (21) | 3 (15.7) | 1 (5.2) | 0 | 0.33 | |
| - | Hematological | ||||||||||
| Anemia | 10 (47.6) | 6 (28.5) | 3 (14.2) | 1 (4.7) | 4 (21) | 4 (21) | 0 | 0 | 0.17 | ||
| Neutropenia | 8 (38) | 3 (14.2) | 4 (19) | 1 (4.7) | 4 (21) | 3 (15.7) | 1 (5.2) | 0 | 0.41 | ||
| Thrombocytopenia | 7 (33.3) | 4 (19) | 3 (14.2) | 0 | 2 (10.5) | 2 (10.5) | 0 | 0 | 0.14 | ||
[i] HFS: Hand and foot syndrome
Table 4
Response data.
| Items | Standard dose | Low dose | P value | |
|---|---|---|---|---|
| - | Complete response | 1 (4.7) | 2 (10.5) | |
| - | Overall clinical response (CR+ PR) | 8 (38) | 7 (36.8) | |
| - | Stable disease | 3 (14.2) | 4 (21) | 0.81 |
| - | Progressive disease | 10 (47.6) | 8 (42.1) | |
| - | Mean TTP | 8.16 ± 0.63 | 8.98 ± 0.75 | 0.66 |
| - | Median TTP | 10.1 | 10 | |
| - | Mean OS | 11.94 ± 0.754 | 11.24± 0.665 | 0.9 |
| - | Median OS | 13.1 | 13 | |
[i] CR: complete response; OS: overall survival; PR: partial response; TTP: time to progression.
Table 5
Relations of response data.
| Prognostic factors | All patients (40) | P value | Standard dose (group 1 = 21) | P value | Low dose (group 2 = 19) | P value | |||
|---|---|---|---|---|---|---|---|---|---|
| Response no. (%) | No response no. (%) | Response no. (%) | No response no. (%) | Response no. (%) | No response no. (%) | ||||
| Age group | |||||||||
| ≤45 years | 7 (17.5) | 8 (20) | 0.001 | 4 (19) | 4 (19) | 0.005 | 3 (15.7) | 4 (21) | 0.075 |
| >45 years | 1 (2.5) | 24 (60) | 0 | 13 (61.9) | 1 (5.2) | 11 (57.8) | |||
| Menopausal state | |||||||||
| Premenopausal | 7 (17.5) | 8 (20) | 0.93 | 4 (19) | 4 (19) | 0.84 | 3 (15.7) | 4 (21) | 0.96 |
| Postmenopausal | 12 (30) | 13 (32.5) | 7 (33.3) | 6 (28.5) | 5 (26.3) | 7 (36.8) | |||
| Grade | |||||||||
| 1 | 3 (7.5) | 0 | 0.015 | 2 (9.5) | 0 | 0.61 | 1 (5.2) | 0 | 0.23 |
| 2 | 5 (12.5) | 18 (45) | 2 (9.5) | 9 (42.8) | 3 (15.7) | 9 (47.3) | |||
| 3 | 7 (17.5) | 7 (17.5) | 4 (19) | 4 (19) | 3 (15.7) | 3 (15.7) | |||
| Triple negative | |||||||||
| No | 14 (35) | 17 (42.5) | 0.063 | 8 (38) | 8 (38) | 0.044 | 6 (31.5) | 9 (47.3) | 0.85 |
| Yes | 1 (2.5) | 8 (20) | 0 | 5 (23.8) | 3 (15.7) | 1 (5.2) | |||
| No. of metastatic sites | |||||||||
| 1 | 10 (25) | 3 (7.5) | 0.01 | 4 (19) | 1 (4.7) | 0.051 | 6 (31.5) | 2 (10.5) | 0.011 |
| 2 | 4 (10) | 10 (25) | 3 (14.2) | 5 (23.8) | 1 (5.2) | 5 (26.3) | |||
| ≥ 3 | 1 (2.5) | 12 (30) | 1 (4.7) | 7 (33.3) | 0 | 5 (26.3) | |||
| Treatment line | |||||||||
| First | 14 (35) | 11 (27.5) | .007 | 7 (33.3) | 6 (28.5) | 0.15 | 7 (36.8) | 5 (26.3) | 0.039 |
| Second | 1 (2.5) | 9 (22.5) | 1 (4.7) | 5 (23.8) | 0 | 4 (21) | |||
| Third or more | 0 | 5 (12.5) | 0 | 2 (9.5) | 0 | 3 (15.7) | |||
Figure 1
Time to progression in both groups.
Figure 2
Overall survival in both groups.