Antitumour antibiotic containing regimens for metastatic breast cancer

Sarah J Lord; Davina Ghersi; Melina Gattellari; Sally Wortley; Nicholas Wilcken; Charlene Thornton; John Simes

doi:10.1002/14651858.CD003367.pub2

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Figure 1

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Figure 2

Summary of regimens included in the analyses

a) Treatment arm = Anthracycline containing regimens

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Figure 3

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Figure 4

Summary of outcomes included in the analyses

a) Treatment arm = Anthracycline containing regimen

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Figure 5

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Analysis 1.1

Comparison 1: Antitumour antibiotic containing regimens vs not: all trials, Outcome 1: Overall survival

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Analysis 1.2

Comparison 1: Antitumour antibiotic containing regimens vs not: all trials, Outcome 2: Time to progression

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Analysis 1.3

Comparison 1: Antitumour antibiotic containing regimens vs not: all trials, Outcome 3: Overall response (assessable patients)

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Analysis 1.4

Comparison 1: Antitumour antibiotic containing regimens vs not: all trials, Outcome 4: Treatment‐related death

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Analysis 2.1

Comparison 2: Antitumour antibiotic regimens containing anthracyclines vs non antitumour antibiotic containing regimens, Outcome 1: Overall survival

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Analysis 2.2

Comparison 2: Antitumour antibiotic regimens containing anthracyclines vs non antitumour antibiotic containing regimens, Outcome 2: Time to progression

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Analysis 2.3

Comparison 2: Antitumour antibiotic regimens containing anthracyclines vs non antitumour antibiotic containing regimens, Outcome 3: Overall response (assessable patients)

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Analysis 2.4

Comparison 2: Antitumour antibiotic regimens containing anthracyclines vs non antitumour antibiotic containing regimens, Outcome 4: Treatment‐related death

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Analysis 3.1

Comparison 3: Sensitivity analysis: anthracyclines vs not, using studies with clearly described allocation concealment, Outcome 1: Overall survival

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Analysis 3.2

Comparison 3: Sensitivity analysis: anthracyclines vs not, using studies with clearly described allocation concealment, Outcome 2: Time to progression

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Analysis 3.3

Comparison 3: Sensitivity analysis: anthracyclines vs not, using studies with clearly described allocation concealment, Outcome 3: Overall response (assessable patients)

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Analysis 4.1

Comparison 4: Subgroup analysis: anthracyclines vs not, by class of comparator, Outcome 1: Overall survival

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Analysis 4.2

Comparison 4: Subgroup analysis: anthracyclines vs not, by class of comparator, Outcome 2: Time to progression

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Analysis 4.3

Comparison 4: Subgroup analysis: anthracyclines vs not, by class of comparator, Outcome 3: Overall response (assessable patients)

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Analysis 5.1

Comparison 5: Mitoxantrone containing regimens vs non antitumour antibiotic containing regimens, Outcome 1: Overall survival

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Analysis 5.2

Comparison 5: Mitoxantrone containing regimens vs non antitumour antibiotic containing regimens, Outcome 2: Time to progression

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Analysis 5.3

Comparison 5: Mitoxantrone containing regimens vs non antitumour antibiotic containing regimens, Outcome 3: Overall response (assessable patients)

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Analysis 5.4

Comparison 5: Mitoxantrone containing regimens vs non antitumour antibiotic containing regimens, Outcome 4: Treatment‐related death

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Table 1. Chemotherapeutic Agents (adapted from Table 1.1 in The Chemotherapy Source Book)

Type of Agent	Action	Includes
Agents that damage the DNA template	by alkylation: nitrogen mustards	cyclophosphamide, melphalan, ifosfamide, chlorambucil
	by alkylation: nitrosureas	carmustine (BCNU), lomustine (CCNU)
	by alkylation: other agents	thiotepa, mitomycin C
	by platinum coordination cross‐linking	cisplatin, carboplatin
	antibiotics	doxorubicin, daunorubicin, mitoxantrone, idarubicin, epirubicin, amsacrine
	podophyllotoxins	etoposide, teniposide
	by intercalation	dactinomycin, mithramycin
	by uncertain mechanisms	bleomycin
Spindle poisons	vinca alkaloids	vincristine, vinblastine, vendesine, vinorelbine
	taxanes	taxol, taxotere
Antimetabolites	thymidylate synthase	5‐fluorouracil
	dihydrofolate reductase	methotrexate

Table 1. Chemotherapeutic Agents (adapted from Table 1.1 in The Chemotherapy Source Book)

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Table 2. Antitumour antibiotics

Generic Name	Other names
doxorubicin hydrochloride	adriamycin, caelyx, doxorubicin, rubex
daunorubicin hydrochloride	cerubidine
dactinomycin	actinomycin D, cosmogen
mitomycin C	mitomycin, mitomycin C, mitomycin‐C, mutamucin
mitozantrone	novantrone, mitoxantrone
epirubicin hydrochloride	ellence, epirubicin, pharmorubicin
plicamycin	mithramycin, mithracin
bleomycin sulfate	blenoxane

Table 2. Antitumour antibiotics

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Table 3. Acute toxicity Grade III‐IV

Site of toxicity	No. of trials	AA events (pts)/n	Ctrl events (pts)/n	OR (95% CI)
ASSESSABLE PTS
All Trials
leukopenia*	26	931/2621	774/2527	1.25 (1.11‐1.41)
nausea or vomiting**	17	341/2150	197/1945	1.71 (1.42‐2.06)
alopecia	22	1177/1800	854/1934	2.36 (2.07‐2.70)
cardiac toxicity	25	94/2572	18/2452	5.91 (3.56‐9.80)

Anthracycline Trials
leukopenia*	22	846/2265	694/2160	1.25 (1.10‐1.41)
nausea or vomiting**	14	327/1852	170/1642	1.98 (1.62‐2.41)
alopecia	18	1097/1447	705/1569	3.87 (3.31‐4.52)
cardiac toxicity	23	92/2451	18/2326	5.17 (3.16‐8.48)

Anthracycline vs CMF based Trials
leukopenia*	19	478/1622	531/1851	1.04 (0.90‐1.20)
nausea or vomiting**	12	236/1359	180/1478	1.52 (1.23‐1.87)
alopecia	16	847/1410	600/1585	2.47 (2.13‐2.86)
cardiac toxicity	17	49/1565	7/1710	7.86 (3.55‐17.41)

Mitoxantrone Trials
leukopenia*	4	85/365	80/367	1.17 (0.84‐1.63)
nausea or vomiting**	3	14/298	27/303	0.64 (0.34‐1.18)
alopecia	4	100/353	149/365	0.66 (0.49‐0.90)
cardiac toxicity	2	2/121	0/126	5.29 (0.25‐111.39)

* data on grade II or IV neutropenia was included if data on leucopenia not reported
** if data on nausea and vomiting was reported separately data on vomiting was included.

Table 3. Acute toxicity Grade III‐IV

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Table 4. Quality of life

Trial ID	Instruments used	Summary of findings
ANZ BCTG 8614	Patients completed 14 linear analogue self‐assessment scales. Clinicians used the Spitzer QL index.	Completion rates for each instrument are not available. No significant differences in patient or clinician rated overall QOL were reported between the treatment groups at 3 months. Patients on CMFP rated significantly higher for mood, pain, feeling sick, vomiting, appetite/taste and sexual interest, but worse for hair loss that patients on MTZ.
Harper Wynne 1999	HADS and RSCL (plus 3 satisfaction questions) pre‐treatment and at weeks 12 and 24 (or on withdrawal)	Only 35 (30%) completed all 3 assessments. Reported no evidence of a difference between treatment groups.
IDBBC EORTC 10923	Patients completed EORTC QLQ‐C30 and Rotterdam Symptom Checklist	64% of randomised patients completed baseline QLQ‐C30 and 61% completed baseline RSCL. QOL comparisons were only performed for the first 3 cycles. Doxorubicin was associated with significantly more nausea/vomiting, loss of appetite and burden of disease and treatment, but less bone pain and rash.
Fraser 1993	Patients completed 3 quality of life instruments: 4 weekly Nottingham Health Profile (NHP ‐ emotional state, energy, pain, physical mobility, sleep and social factors ) and Linear Analogue Self‐Assessment (LASA) at the start of treatment and four weekly thereafter and the Qualitator daily dairy card throughout treatment which measured the domains of physical symptoms, social factors, emotional factors and physical performance.	Of the 40 patients randomised, compliance for the 29 who started the Qualitator, the 37 who started the NHP and 36 who started the LASA respectively were 88%, 89% and 92%. Quality of life measures only recorded a significant difference in energy and pain, influenced primarily by the non responders in each treatment group but with no difference in overall global scores. Scores for responders (58% for CMF, 29% for epirubicin P>0.05), irrespective of treatment were better to start with (LASA P=0.001); at 12 weeks, scores had improved (Qualitator P<0.05; NHP P<0.05) . Scores in non responders showed no change.

Table 4. Quality of life

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Comparison 1. Antitumour antibiotic containing regimens vs not: all trials

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Overall survival Show forest plot	35	5605	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.96 [0.90, 1.02]

1.1.1 Regimen A plus antitumour antibiotic vs Regimen A	4	547	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.90 [0.72, 1.13]
1.1.2 Regimen A plus antitumour antibiotic vs Regimen B	25	3818	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.94 [0.87, 1.02]
1.1.3 Single agent antitumour antibiotic vs Regimen C	6	1240	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	1.03 [0.92, 1.16]
1.2 Time to progression Show forest plot	14	2815	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.84 [0.77, 0.91]

1.2.1 Regimen A plus antitumour antibiotic vs Regimen A	2	78	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.67 [0.37, 1.24]
1.2.2 Regimen A plus antitumour antibiotic vs Regimen B	10	2015	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.83 [0.75, 0.92]
1.2.3 Single agent antitumour antibiotic vs Regimen C	2	722	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.86 [0.74, 1.00]
1.3 Overall response (assessable patients) Show forest plot	45	6538	Odds Ratio (M‐H, Fixed, 95% CI)	1.33 [1.21, 1.48]

1.3.1 Regimen A plus antitumour antibiotic vs Regimen A (assessable patients)	5	604	Odds Ratio (M‐H, Fixed, 95% CI)	1.90 [1.33, 2.72]
1.3.2 Regimen A plus antitumour antibiotic vs Regimen B (assessable patients)	32	4439	Odds Ratio (M‐H, Fixed, 95% CI)	1.43 [1.27, 1.62]
1.3.3 Single agent antitumour antibiotic vs Regimen C (assessable patients)	9	1495	Odds Ratio (M‐H, Fixed, 95% CI)	0.92 [0.74, 1.15]
1.4 Treatment‐related death Show forest plot	20	4364	Odds Ratio (M‐H, Fixed, 95% CI)	1.18 [0.77, 1.83]

1.4.1 Regimen A plus antitumour antibiotic vs Regimen A	1	345	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.54]
1.4.2 Regimen A plus antitumour antibiotic vs Regimen B	15	3242	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.61, 1.67]
1.4.3 Single agent antitumour antibiotic vs Regimen C	4	777	Odds Ratio (M‐H, Fixed, 95% CI)	2.26 [0.80, 6.41]

Comparison 1. Antitumour antibiotic containing regimens vs not: all trials

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Comparison 2. Antitumour antibiotic regimens containing anthracyclines vs non antitumour antibiotic containing regimens

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Overall survival Show forest plot	31	4846	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.97 [0.91, 1.04]

2.1.1 Regimen A plus anthracycline vs Regimen A	4	553	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	1.01 [0.83, 1.24]
2.1.2 Regimen A plus anthracycline vs Regimen B	22	3445	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.95 [0.88, 1.03]
2.1.3 Single agent anthracycline vs Regimen C	5	848	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	1.02 [0.87, 1.20]
2.2 Time to progression Show forest plot	12	2226	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.76 [0.69, 0.83]

2.2.1 Regimen A plus anthracycline vs Regimen A	2	78	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.67 [0.37, 1.24]
2.2.2 Regimen A plus anthracycline vs Regimen B	9	1817	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.82 [0.74, 0.91]
2.2.3 Single agent anthracycline vs Regimen C	1	331	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.55 [0.44, 0.68]
2.3 Overall response (assessable patients) Show forest plot	42	5786	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [1.26, 1.56]

2.3.1 Regimen A plus anthracycline vs Regimen A (assessable patients)	5	604	Odds Ratio (M‐H, Fixed, 95% CI)	1.90 [1.33, 2.72]
2.3.2 Regimen A plus anthracycline vs Regimen B (assessable patients)	29	4078	Odds Ratio (M‐H, Fixed, 95% CI)	1.44 [1.27, 1.63]
2.3.3 Single agent anthracycline vs Regimen C (assessable patients)	8	1104	Odds Ratio (M‐H, Fixed, 95% CI)	1.09 [0.85, 1.41]
2.4 Treatment‐related death Show forest plot	18	4117	Odds Ratio (M‐H, Fixed, 95% CI)	1.16 [0.74, 1.82]

2.4.1 Regimen A plus anthracycline vs Regimen A	1	345	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.18, 5.54]
2.4.2 Regimen A plus anthracycline vs Regimen B	13	2995	Odds Ratio (M‐H, Fixed, 95% CI)	0.97 [0.57, 1.64]
2.4.3 Single agent anthracycline vs Regimen C	4	777	Odds Ratio (M‐H, Fixed, 95% CI)	2.26 [0.80, 6.41]

Comparison 2. Antitumour antibiotic regimens containing anthracyclines vs non antitumour antibiotic containing regimens

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Comparison 3. Sensitivity analysis: anthracyclines vs not, using studies with clearly described allocation concealment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Overall survival Show forest plot	6	1439	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.88 [0.78, 0.99]

3.1.1 Regimen A plus anthracycline vs Regimen A	0	0	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	Not estimable
3.1.2 Regimen A plus anthracycline vs Regimen B	5	1108	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.86 [0.75, 0.98]
3.1.3 Single agent anthracycline vs Regimen C	1	331	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.93 [0.73, 1.19]
3.2 Time to progression Show forest plot	4	1134	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.71 [0.63, 0.80]

3.2.1 Regimen A plus anthracycline vs Regimen A	0	0	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	Not estimable
3.2.2 Regimen A plus anthracycline vs Regimen B	3	803	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.80 [0.69, 0.92]
3.2.3 Single agent anthracycline vs Regimen C	1	331	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.55 [0.44, 0.68]
3.3 Overall response (assessable patients) Show forest plot	10	1765	Odds Ratio (M‐H, Fixed, 95% CI)	1.63 [1.35, 1.98]

3.3.1 Regimen A plus anthracycline vs Regimen A (assessable patients)	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.3.2 Regimen A plus anthracycline vs Regimen B (assessable patients)	9	1434	Odds Ratio (M‐H, Fixed, 95% CI)	1.56 [1.26, 1.94]
3.3.3 Single agent anthracycline vs Regimen C (assessable patients)	1	331	Odds Ratio (M‐H, Fixed, 95% CI)	2.02 [1.26, 3.22]

Comparison 3. Sensitivity analysis: anthracyclines vs not, using studies with clearly described allocation concealment

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Comparison 4. Subgroup analysis: anthracyclines vs not, by class of comparator

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Overall survival Show forest plot	29	4438	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.95 [0.89, 1.02]

4.1.1 Anthracyclines vs C+ comparator	8	506	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	1.25 [0.99, 1.57]
4.1.2 Anthracyclines vs CMF comparator	13	2136	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.95 [0.86, 1.05]
4.1.3 Anthracyclines vs CMF+ comparator	5	767	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.84 [0.72, 0.99]
4.1.4 Anthracyclines vs taxane comparator	3	1029	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.96 [0.83, 1.10]
4.2 Time to progression Show forest plot	11	1899	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.76 [0.69, 0.83]

4.2.1 Anthracyclines vs C+ comparator	5	304	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.96 [0.73, 1.26]
4.2.2 Anthracyclines vs CMF comparator	4	999	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.82 [0.72, 0.93]
4.2.3 Anthracyclines vs CMF+ comparator	1	265	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.72 [0.57, 0.90]
4.2.4 Anthracyclines vs taxane comparator	1	331	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.55 [0.44, 0.68]
4.3 Overall response (assessable patients) Show forest plot	41	5493	Odds Ratio (M‐H, Fixed, 95% CI)	1.41 [1.26, 1.58]

4.3.1 Anthracyclines vs C+ comparator	10	567	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.87, 1.76]
4.3.2 Anthracyclines vs CMF comparator	18	2515	Odds Ratio (M‐H, Fixed, 95% CI)	1.41 [1.20, 1.66]
4.3.3 Anthracyclines vs CMFVP comparator	10	1396	Odds Ratio (M‐H, Fixed, 95% CI)	1.38 [1.11, 1.72]
4.3.4 Anthracyclines vs taxane comparator	3	1015	Odds Ratio (M‐H, Fixed, 95% CI)	1.57 [1.20, 2.06]

Comparison 4. Subgroup analysis: anthracyclines vs not, by class of comparator

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Comparison 5. Mitoxantrone containing regimens vs non antitumour antibiotic containing regimens

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Overall survival Show forest plot	4	763	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.95 [0.81, 1.12]

5.1.1 Regimen A plus mitoxantrone vs Regimen A	0	0	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	Not estimable
5.1.2 Regimen A plus mitoxantrone vs Regimen B	3	372	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.83 [0.63, 1.10]
5.1.3 Single agent mitoxantrone vs Regimen C	1	391	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	1.02 [0.83, 1.25]
5.2 Time to progression Show forest plot	3	635	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.84 [0.72, 0.98]

5.2.1 Regimen A plus mitoxantrone vs Regimen A	0	0	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	Not estimable
5.2.2 Regimen A plus mitoxantrone vs Regimen B	2	244	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	1.02 [0.75, 1.39]
5.2.3 Single agent mitoxantrone vs Regimen C	1	391	Peto Odds Ratio (Exp[(O‐E) / V], Fixed, 95% CI)	0.79 [0.65, 0.94]
5.3 Overall response (assessable patients) Show forest plot	4	752	Odds Ratio (M‐H, Fixed, 95% CI)	0.88 [0.64, 1.19]

5.3.1 Regimen A plus mitoxantrone vs Regimen A (assessable patients)	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.3.2 Regimen A plus mitoxantrone vs Regimen B (assessable patients)	3	361	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [0.90, 2.18]
5.3.3 Single agent mitoxantrone vs Regimen C (assessable patients)	1	391	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.36, 0.86]
5.4 Treatment‐related death Show forest plot	2	247	Odds Ratio (M‐H, Fixed, 95% CI)	1.58 [0.26, 9.44]

5.4.1 Regimen A plus mitoxantrone vs Regimen A	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
5.4.2 Regimen A plus mitoxantrone vs Regimen B	2	247	Odds Ratio (M‐H, Fixed, 95% CI)	1.58 [0.26, 9.44]
5.4.3 Single agent mitoxantrone vs Regimen C	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 5. Mitoxantrone containing regimens vs non antitumour antibiotic containing regimens

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