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Comparative study of low dose of capecitabine versus standard dose in metastatic breast cancer: Efficacy and safety

Engy M Aboelnaga
Engy M Aboelnaga
 und 
Wafaa El-beshbishi
Wafaa El-beshbishi
   | 09. Aug. 2021
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Article Category: Research Article
Online veröffentlicht: 09. Aug. 2021
Seitenbereich: 12 - 21
Eingereicht: 05. Juli 2019
Akzeptiert: 05. Nov. 2019
DOI: https://doi.org/10.2478/fco-2019-0015
Schlüsselwörter
© 2021 Engy M Aboelnaga et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Figure 1

Time to progression in both groups.
Time to progression in both groups.

Figure 2

Overall survival in both groups.
Overall survival in both groups.

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%)

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

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)

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

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
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